Pharmaceutical chemistry and technology Books

Book SynopsisThis text is aimed at potential clinical investigators usually physicians, especialy those thinking about doing clinical trials to evaluate new drugs - mostly sponsored by pharmaceutical companies.Table of ContentsIn this book a respected clinical investigator shares his experiences and insights, so that others can share in the excitement of clinical research while avoiding some of the pitfalls that inevitably beset the clinical trialist. This book provides practical advice on how to interact with various ...monitors..., auditors, and project leaders running a trial. It also gives advice on how to recruit patients to the trials. The author examines subjects such as allocation of time, space, and staff. This book is predominantly aimed at doctors performing clinical trials for pharmaceutical companies and will be of great help to Heads of Clinical Research in pharmaceutical companies--also to academic staff in university clinical departments, particularly pharmacology.

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Book SynopsisThis book traces the evolution of the pharmacist from compounder-dispenser to advisor counselor. It explores the impact on pharmacy of broad sociologic, demographic, and economic trends and examines controversial issues such as professional versus business objectives, managed cost care, coginitive services, pharmaceutical care, and the future roles

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Book SynopsisThis revised and updated new edition of a best-selling text remains a fast and convenient overview of the clinical trials in gynecologic cancer treatment, outlining the evidence base of treatment decisions in uterine, ovarian, cervical, and vulvar cancers, and gestational trophoblastic neoplasia. Residents and fellows will find this book an indispensable reference, while practitioners will welcome it as a clarification of the evidence base for treatment options. *Gives a convenient summary of trials in gynecologic oncology *Supplies an invaluable revision primer for those undertaking certification *Provides a uniquely up-to-date resourceTable of ContentsPreface to the second edition1. Uterine Malignancies. 1.1. Endometrial Carcinoma. 1.1.1. Studies addressing surgical treatment. 1.1.1.1. Lymph node assessment 1.1.2. Studies addressing adjuvant therapy. 1.1.2.1. Radiation. 1.1.2.2. Chemoradiation. 1.1.2.3. Chemotherapy. 1.1.3. Studies addressing treatment of recurrent endometrial carcinoma. 1.1.3.1. Hormonal therapy. 1.1.3.2. Chemotherapy. 1.1.3.3. Targeted therapy. 1.1.3.4. Immunotherapy. 1.2. Uterine Carcinosarcoma. 1.2.1. Studies addressing prognosticators. 1.2.2. Studies addressing adjuvant treatment. 1.2.3. Studies addressing treatment of advanced/ recurrent uterine carcinosarcoma. 1.3. Uterine Leiomyosarcoma. 1.3.1. Studies addressing adjuvant treatment of early stage uterine leiomyosarcoma. 1.3.2. Studies addressing treatment of advanced uterine leiomyosarcoma. 1.4. References.2. Ovarian Malignancies. 2.1. Epithelial ovarian cancer (EOC). 2.1.1. Studies addressing upfront surgery. 2.1.2. Studies addressing adjuvant therapy. 2.1.3. Studies addressing intraperitoneal chemotherapy. 2.1.4. Studies addressing first line maintenance treatment. 2.1.5. Studies addressing neoadjuvant therapy. 2.1.6. Studies addressing prediction of debulking. 2.1.7. Studies addressing time point of treatment of recurrence. 2.1.8. Studies addressing treatment of recurrent ovarian cancer, platinum-sensitive. 2.1.8.1. Chemotherapy and targeted therapy. 2.1.8.2. Secondary debulking surgery. 2.1.9. Studies addressing treatment of recurrent ovarian cancer, platinum-resistant. 2.1.9.1. Chemotherapy and targeted therapy. 2.1.9.2. Immunotherapy. 2.2. Low grade serous ovarian cancer. 2.3. Mucinous epithelial ovarian cancer (mEOC). 2.4. Ovarian Germ Cell Tumors (GCT). 2.5. Ovarian Sex Cord-Stromal Tumors (SCT). 2.6. References.3. Cervical Cancer. 3.1. Studies addressing surgical treatment. 3.2. Studies addressing adjuvant therapy. 3.3. Studies addressing primary chemoradiation therapy. 3.4. Studies addressing treatment of recurrent or metastatic cervical cancer. 3.4.1. Chemotherapy and targeted therapy. 3.4.2. Immunotherapy. 3.5. References.4. Vulvar Cancer. 4.1. Studies addressing surgical treatment. 4.1.1. Groin lymph nodes. 4.2. Studies addressing advanced vulvar cancer. 4.2.1. Chemoradiation. 4.2.2. Immunotherapy. 4.3. References.5. Gestational Trophoblastic Neoplasia (GTN). 5.1. Studies addressing surgical treatment. 5.2. Studies addressing chemotherapy in low-risk GTN. 5.3. Studies addressing (chemo)therapy in high-risk GTN. 5.4. References.6. Glossary. Index.

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Book SynopsisThe book reviews the recent research advances and their outcomes in the areas of structural biology, bioinformatics, phytochemistry and drug discovery. Chapters in the book cover multidisciplinary research to understand the molecular mechanisms involved in protein-protein/ligand interactions. It employs an integrative approach to identify the therapeutic targets for HIV, and cancer, pathogen and viral infection pathways and the identification of their potential drug candidates. The book also provides examples of computational molecular dynamics simulations to understand the conformational changes in the molecules. Some chapters are focused on exploring potent bioactive compounds from natural sources.This book can serve as a single source that covers several interdisciplinary research fields which will be beneficial to Researchers and students in postgraduate studies.

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Book SynopsisUsing time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or noninformativeness of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest.After reviewing time-to-event endpoint methodology, clinical trial issues, and the design and monitoring of clinical trials, the book focuses on inferential analysis methods, including parametric, semiparametric, categorical, and Bayesian methods; an alternative to the Cox model for small samples; and estimation and testing for change in hazard. It then presents descriptive and graphical methods useful in the analysis of time-to-event endpoints. The next several chapters explore a variety of Trade Review… One of the strengths of the book is the collection, discussion and illustration of the many diverse time-to-event problems that may occur in practice. … this publication provides a comprehensive overview of classical and emerging ideas in the analysis of time-to-event problems. Written by experts in their area, the book has a wealth of references in each topic should the reader wish to learn about or extend their understanding of individual concepts or analysis methods. It is a worthwhile book to have in the library for anyone working in designing, conducting, analysing or interpreting studies with time-to-event outcomes.—Australian & New Zealand Journal of Statistics, 2011Table of ContentsOverview of Time-to-Event Endpoint Methodology. Design (and Monitoring) of Clinical Trials with Time-to-Event Endpoints. Overview of Time-to-Event Parametric Methods. Overview of Semiparametric Inferential Methods for Time-to-Event Endpoints. Overview of Inferential Methods for Categorical Time-to-Event Data. Overview of Bayesian Inferential Methods Including Time-to-Event Endpoints. An Efficient Alternative to the Cox Model for Small Time-to-Event Trials. Estimation and Testing for Change in Hazard for Time-to-Event Endpoints. Overview of Descriptive and Graphical Methods for Time-to-Event Data. Design and Analysis of Analgesic Trials. Design and Analysis of Analgesic Trials with Paired Time-to-Event Endpoints. Time-to-Event Endpoint Methods in Antibiotic Trials. Design and Analysis of Cardiovascular Prevention Trials. Design and Analysis of Antiviral Trials. Cure Rate Models with Applications to Melanoma and Prostate Cancer Data. Parametric Likelihoods for Multiple Nonfatal Competing Risks and Death, with Application to Cancer Data. Design, Summarization, Analysis, and Interpretation of Cancer Prevention Trials. LASSO Method in Variable Selection for Right-Censored Time-to-Event Data with Application to Astrocytoma Brain Tumor and Chronic Myelogenous Leukemia. Selecting Optimal Treatments Based on Predictive Factors. Application of Time-to-Event Methods in the Assessment of Safety in Clinical Trials. Design and Analysis of Chronic Carcinogenicity Studies of Pharmaceuticals in Rodents. Design and Analysis of Time-to-Tumor Response in Animal Studies: A Bayesian Perspective. Index.

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Book SynopsisRegulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.Table of ContentsClinical Research – A Clinical Investigator’s PerspectiveIntroduction Scientific and Practical Aspects Financial ConsiderationsMedical Device Development, Process and RegulationIntroduction Categories of Medical Devices Evaluation of Medical Devices Regulatory Process Pre-Clinical Drug DevelopmentIntroduction Overview of Drug Discovery and Role of basic Sciences New Approaches in Drug Discovery Pharmacological Screening Phases of Clinical TrialsIntroduction Phase I Phase II Studies Phase III Trials Phase IV Trials Phase 0 - Microdosing StudiesIntroduction Micro-dosing and Exploratory-IND StudiesCharacteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies Goals of Microdosing StudiesTechnical Advances Regulatory IssuesPatient’s PerspectiveInformed Consent Issues Single-dose Toxicity Study in Support of Micro-dosing StudiesAdvantages of Micro-dosingLimitations of Micro-dosing Conclusion Clinical Research PlanningIntroduction to Clinical Trials Types of Clinical TrialsThe Planning StepsClinical Research DesignIntroduction Elements of Trial DesignTypes of Clinical Trial DesignClinical Research ProtocolTitle Page Signature PageContents Page List of Abbreviations and Definitions Summary BackgroundTrial Objectives and Purpose Study DesignSubject Selection Subject Recruitment Trial Interventions Randomisations Blinding Data Statistical Considerations Compliance and Withdrawal Interim Analysis and Data MonitoringEthical Considerations Financing and Insurance Reporting and Publication Designing Case Report FormsIntroduction Uses of CRFWell-Designed CRF CRF Design Layout CRF Field Designs CRF Verification Before Use Elements of Trial Design Electronic Data Entry Forms Conclusion Points to Remember Process of Randomization in Clinical TrialsIntroduction Advantages of Randomization Types of Randomization Techniques of Randomisation Implementation of Randomization Procedure Investigational Medicinal ProductsDefinition Manufacturing, Packaging, Labeling, and Coding IMPsSupply and Handling IMPs Receipt of IMP, Inventory, Storage and Accountability Randomization Code Principles Applicable to Comparator Product Blinding Operations Recall, Return, Shipment and Destruction of IMP Multi-center Clinical TrialsIntroduction Advantages and DisadvantagesA Common Protocol A Coordinating Centre Comparability of Participating institutions Committees in a Multi-center Trial Statistical Issues Analysis of Results Multinational Clinical Trials Good Clinical Research PracticeIntroduction Definition of GCPOverview of the Clinical Research Process Principles of GCPRole and Responsibilities of SponsorIntroduction Contract Research Organization (CRO) The Sponsor and the investigational Products Sponsor and Record Access Safety Information Role and Responsibilities of Principal InvestigatorIntroduction Competencies and Responsibilities of the Principal Investigator Qualifications and Availability Adequate Resources Informed Consent Investigational Products Compliance with Protocol Monitoring and Auditing Source Data and Other Documentation Safety Issues and Reporting of Serious Adverse Events Premature Termination - Breaking the Treatment Code Progress Reports, Trial Outcome and Final Study Reports Ethical Consideration in Clinical Research – Special Reference to Developing CountriesIntroduction Individuals Involved With Ethical Issues Ethical Issues Related to Protocol Development and Study DesignIssues on Informed Consent Ethical Issues During Conduct of a Clinical Research Access to Post Trial Benefits Need for Developed Countries to Assist DevelopingCountries in Capacity Building Informed Consent in Clinical ResearchIntroduction Historical Background Elements of Informed Consent Language Used in Consent Forms Informed Consent Waiver Revising an Informed ConsentReconsenting Process Consent Obtained from Special Groups of Patients Monitoring in Clinical TrialsIntroduction Types of Monitoring in Clinical Trials Key Participant in Monitoring of Clinical Trial Quality Assurance in Clinical ResearchMonitoring-Details Presented in Chapter on Monitoring Audit Inspections Data Management Metrics Pharmacovigilance and Drug SafetyIntroduction Terms Commonly Used in Drug Safety The Specific Aims of Pharmacovigilance Definitions ADR Classification and Evolution Causality Assessment Scales Important of Post Marketing Surveillance and ADR Reporting Characteristics of a Good Adverse Drug Reaction Report Periodic Safety Update Report (PSUR) MedDRA or Medical Dictionary for Regulatory Activities Pharmacovigilance in India Data and Safety Monitoring Board and Monitoring PlanDefinition and Purpose Data Monitoring Committee Data Safety Monitoring Plan Standard Operating ProceduresIntroduction Standard Operating Procedures SOP Template Master Formulation Record Archiving Clinical Research DocumentsIntroduction Stake Holders What Documents Must Be Archived How long Should the Documents be Archived When to Archive Trail Master File (TMF) The Archive BuildingEvidence Based MedicineIntroduction and Overview History Types of EBM Categories of Evidence Categories of Recommendations Statistical Measures Quality of Clinical Trial Publications Limitations of Available Evidence Criticism of Evidence-Based Medicine Clinical Research Data ManagementIntroduction Protocol Randomisation Data Management Final Study Report Retension and Securing of Records Archiving by the Principle Investigator Archiving by the Sponsor Clinical Biostatistics(a) Biostatistics for Clinical Researcher26(a).1 Introduction26(a).2 Descriptive Statistics 26(a).3 Null Hypothesis and Alternative Hypothesis 26(a).4 Classifications of Data 26(a).5 Test of Hypothesis with the Correct Statistical Tests 26(a).6 Summary (b) Terminology Used in Biostatistics26(b).1 Introduction to Biostatistics 26(b).2 Terminology used in Biostatistics 26(b).3 Sampling Unit Glossary

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Book SynopsisClinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial.After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.Trade Review… There is much good material in this book. The individual chapters are well written and cover the technical aspects as well. A major strength is the ordering of topics to follow the thought process used in the development and implementation of a protocol from defining the question to reporting results. There are careful discussions on fundamental principles and the pivotal role played by statistics is well brought out. … there is much that practicing pharmaceutical statisticians will find useful in this book. They will find the coverage of fundamental principles useful and the technical content of the book a good reference source. …—Pharmaceutical Statistics, 2010… fits the need for a contemporary text and handbook that is oriented toward the clinical trial statistician. I highly recommend it and look forward to using it as both a primary and supplemental text in our curriculum, as well as a research resource.—James J. Dignam, University of Chicago, JASA, March 2009The (technical) statistical content is the main focus of the book and this is what helps it to stand apart from most others on clinical trials (even the more obviously statistically orientated ones). It takes the reader to quite a technical background that would serve him or her well if moving on to research problems in the various areas covered, yet does not lose sight of practical issues. … For those of us with the interest (and need) to grapple with these more statistical issues, I wholeheartedly recommend it.—Biometrics, December 2008…The book is very well written and clear. … the authors generally strike the right balance for the intended audience. The inclusion of many historically important as well as contemporary examples to illustrate various points throughout the text is a major strength, as is the inclusion of several modern topics not seen in other texts. As a basis for a course in clinical trials for graduate students in biostatistics, this book is outstanding. In addition, statisticians in the pharmaceutical industry, government, or academia … will find this text extremely informative and useful.” —Michael P. McDermott, University of Rochester Medical Center, Journal of Biopharmaceutical Statistics, 2008Table of ContentsPreface. Introduction to Clinical Trials. Defining the Question. Study Design. Sample Size. Randomization. Data Collection and Quality Control. Survival Analysis. Longitudinal Data. Quality of Life. Data Monitoring and Interim Analysis. Selected Issues in the Analysis. Closeout and Reporting. Special Topics. Appendix. References. Index.

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Book SynopsisOrganic chemistry plays a vital role in the pharmaceutical industry. Knowledge of organic compounds is used to inform research and further the discovery and development of new medicines. Likewise, organic chemistry is fundamental to understanding biological reactions, mechanisms and all life sciences in general. Basic Chemistry for Life Science Students and Professionals is an ideal introduction to organic chemistry in the context of the life sciences and pharmacy related disciplines; utilising drug molecules to illustrate the chemical basis of their efficacy and interaction with biological targets. This book builds upon the basic concepts of organic chemistry to develop the reader’s understanding of the importance of organic chemistry to the life sciences from natural product sources, their synthesis, and approaches to drug discovery. Ideal for undergraduate students in the natural sciences, this book is also an excellent primer for postgraduates in a variety of disciplines including forensic science and allied-health programmes as well as professionals working in related fields seeking a comprehensive introduction to organic chemistry in the context of pharmaceuticals.Table of ContentsIntroduction to Organic Compounds and Covalent Bonding; Polarity of Bonds, Electronegativity, and Intermolecular Forces; Types of Organic Compounds, Nomenclature, and Basic Reactions: Alkanes and Cycloalkanes; Types of Organic Compounds, Nomenclature, and Basic Reactions: Alkenes, Cycloalkenes and Other Unsaturated Hydrocarbons; 5 Types of Organic Compounds, Nomenclature, and Basic Reactions: Functional Groups; Isomerism in Organic Compounds and Drug Molecules: Chemistry and Significance in Biology; Organic Macromolecules in Cellular Structures, Metabolism, and as Drugs: From Amino Acids to Proteins; Organic Macromolecules in Cellular Structures, Metabolism, and as Drugs: From Monosaccharides to Complex Carbohydrates; Organic Macromolecules in Cellular Structures, Metabolism, and as Drugs: From Fatty Acids to Complex Lipids and Fat; Organic Macromolecules in Cellular Structures, Metabolism, and as Drugs: From Nucleotides to Nucleic Acids; Physicochemical Properties of Organic Compounds and Drug Molecules; Drug-Target Interactions; Structural Diversity and Sources of Drugs: From Nature to Synthetic and Recombinant DNA Technology

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Book SynopsisTable of ContentsPreface ....................................................................... vii Contributors ............................................................. ix Acknowledgements .................................................. xiii What is 'pharmaceutics'?......................................... xv Kevin M.G. Taylor and Michael E. Aulton 1. Design of dosage forms.................................. 1 Peter York 2. Dissolution and solubility ............................. 13 Michael E. Aulton 3. Properties of solutions ................................... 30 Michael E. Aulton 4. Surfaces and interfaces ................................... 39 Graham Buckton 5. Disperse systems.............................................. 50 David Attwood 6. Rheology........................................................... 81 Christopher Marriott 7. Kinetics ............................................................. 101 Gareth R. Williams and John P. Malkinson 8. Solid-state properties .................................... 114 Graham Buckton 9. Particle size analysis ..................................... 126 Kevin M.G. Taylor 10. Particle size reduction and size separation....................................................... 143 Michael E. Aulton 11. Mixing............................................................. 156 Andrew M. Twitchell 12. Powder flow................................................... 172 Michael E. Aulton 13. Fundamentals of microbiology................... 184 Lara-Marie Barnes and Geoffrey W. Hanlon 14. Pharmaceutical applications of microbiological techniques.......................... 208 Lara-Marie Barnes and Norman A. Hodges 15. Action of physical and chemical agents on microorganisms....................................... 229 Lara-Marie Barnes, Geoffrey W. Hanlon and Norman A. Hodges 16. Principles of sterilization ............................. 247 Susannah E. Walsh, Katie Laird and Jean-Yves Maillard 17. Sterilization in practice ................................ 257 Jean-Yves Maillard, Katie Laird and Susannah E. Walsh 18. Introduction to biopharmaceutics.............. 275 Marianne Ashford and Kevin M.G. Taylor 19. Gastrointestinal tract e physiology and drug absorption............................................. 279 Marianne Ashford and Kevin M.G. Taylor 20. Bioavailability e physicochemical, dosage form and formulation factors ........ 297 Marianne Ashford, Kevin M.G. Taylor and Hala M. Fadda 21. Assessment of biopharmaceutical properties ....................................................... 320 Marianne Ashford and Kevin M.G. Taylor 22. Dosage regimens ........................................... 343 Soraya Dhillon and Nkiruka Umaru 23. Pharmaceutical preformulation .................. 360 Simon Gaisford 24. Solutions ........................................................ 386 Sudaxshina Murdan 25. Clarification ................................................... 397 Andrew M. Twitchell 26. Suspensions ................................................... 407 Susan A. Barker 27. Emulsions and creams ................................. 424 Gillian M. Eccleston 28. Ointments, pastes, gels, cutaneous patches and topical sprays........................... 453 Majella E. Lane 29. Powders, granules and granulation ............ 463 Michael E. Aulton 30. Drying............................................................. 483 Michael E. Aulton and Satyanarayana Somavarapu 31. Tablets and compaction............................... 501 Göran Alderborn and Göran Frenning 32. Modified-release oral drug delivery ............ 542 Emma L. McConnell, Christine M. Madla and Abdul W. Basit 33. Coating of tablets and multiparticulates ... 558 Stuart C. Porter 34. Continuous manufacturing of tablets ........ 574 Aktham Aburub and Hala M. Fadda 35. Hard capsules ................................................ 586 Brian E. Jones 36. Soft capsules .................................................. 599 Stephen Tindal 37. Dissolution testing of solid dosage forms............................................................... 612 Ana Cristina Freire, Francesca K.H. Gavins and Abdul W. Basit 38. Parenteral drug delivery ............................... 626 Robert Lowe 39. Pulmonary drug delivery ............................. 641 Kevin M.G. Taylor 40. Nasal drug delivery....................................... 658 Gary P. Martin and Alison B. Lansley 41. Ocular drug delivery..................................... 677 Hala Fadda, Ashkan Khalili, Peng Tee Khaw and Steve Brocchini 42. Otic drug delivery ......................................... 701 Xu Liu, Hugh Smyth and Feng Zhang 43. Topical and transdermal drug delivery ...... 713 Adrian C. Williams 44. Rectal and vaginal drug delivery................. 735 Kalliopi Dodou 45. Preparation and delivery of biopharmaceuticals....................................... 752 Ijeoma F. Uchegbu and Andreas G. Schätzlein 46. Pharmaceutical nanotechnology and nanomedicines .............................................. 768 Yvonne Perrie 47. Radiopharmaceuticals................................... 789 Neil Hartman and Margaret Cooper 48. The formulation and manufacture of plant medicines............................................. 805 G. Brian Lockwood 49. Design and administration of medicines for paediatric and geriatric patients............ 818 Catherine Tuleu, Mine Orlu and David Wright 50. Packaging ....................................................... 833 Sudaxshina Murdan 51. Chemical stability in dosage forms............ 848 Andrew R. Barnes and Mark Santillo 52. Microbial contamination, spoilage and preservation of medicines............................ 860 Norman A. Hodges and Lara-Marie Barnes 53. Product stability and stability testing......... 871 Paul Marshall 54. Pharmaceutical quality: the application of pharmaceutics in medicines regulation ....................................................... 894 Kevin M.G. Taylor, Majella E. Lane and Khalid A. Sheikh Self-assessment questions Sudaxshina Murdan Please check your eBook at https://studentconsult. inkling.com/ for self-assessment questions. See inside cover for registration details. Index.......................................................................... 915

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Book SynopsisIn this book we present recent studies that have been carried out on some widely used medicinal plants. The need for new and alternative treatments stem from the lack of efficiency of existing remedies for certain illnesses. We have compiled information that may be useful to researchers in their quest to develop new drugs.Table of ContentsPart 1: Ethnobotany 1. The Genus Aloysia Paláu (Verbenaceae) in Argentina. A Paradigm in Ethnobotany 2. Ethnobotany of Medicinal and Sacred Plants with Ethnopharmacological Potential from Southwestern Colombia 3. Ethnobotanical Uses and Potential Pharmaceutical Applications of the Cactaceae Family 4. Traditional Use of Plants in Mexico for the Treatment of Diabetes: An Ethnopharmacological Review and Scientific Evaluations 5. Limits and Risks of Plants Valorization in Morocco Associated with Their Vernacular Names 6. Resilience of Mapuche Health System and the Influence of COVID-19 Part 2: Traditional Knowledge of Useful Plants 7. Medicinal Use of the Plants of the Atacama Desert 8. Local Botanical Knowledge of Plants Associated with Andean and Chinese Traditions in the Metropolitan Area of Buenos Aires (Argentina): An Urban Ethnobotany Study 9. Traditional Uses, Phytochemistry, and Pharmacology of Mopane (Colophospermum mopane) in Southern African Countries 10. Traditional Medicine of the Kichwa of the Upper Napo 11. Traditional Practices Regarding the Use of Botanicals to Treat Bovine Haemonchosis in Pakistan

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Book SynopsisHerbal Treatment of Anxiety: Clinical Studies in Western, Chinese and Ayurvedic Traditions explains the nature and types of anxiety, its neurobiology, the pathophysiology that exacerbates and perpetuates it, and the psychopharmacology of the chemical agents that relieve its manifestations. Throughout the text are discussions of Western, Chinese and Ayurvedic herbal treatments that have been clinically shown to be effective in relieving anxiety. The book also features a scientific discussion of the use of herbs and essential oils in aromatherapy and the mechanisms by which they may work. The book concludes by providing bases upon which herbs can be chosen to treat the anxiety of patients according to their individual needs.Additional features include: Examines the increasingly popular subject of the use of herbs as a natural alternative treatment and provides a much-needed scientific basis for treatments often considered as merely folk medicine. Discusses the psychoactive phytochemicals contained in herbs. Includes a chapter discussing the nature and mechanisms of action of adaptogens. Adds to the armamentarium of anxiolytics for providers who have become reluctant to prescribe benzodiazepines as treatment of anxiety, particularly in the context of the opiate crisis. Gives an introduction to herbal treatments of traditional Chinese and Ayurvedic medicine. Offers practical advice on initiating and managing herbal treatments. Herbal Treatment of Anxiety is a valuable reference for psychiatrists, psychiatric nurse practitioners, primary care providers, naturopathic doctors and therapists interested in the most current scientific information on the effects of herbal treatments of anxiety disorders.

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Book SynopsisOligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. A strong collaboration among thirty leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use.Topics discussed include: Strategies for enzymatic or chemical degradation of chemically modified oligonucleotides toTrade ReviewThis is a unique resource for guiding the analysis of oligonucleotide-based drug products. No other single source provides such a comprehensive overview of the necessary analytical techniques that assess the qualitative characteristics of oligonucleotides intended for pharmaceutical use.—Rachel R Chennault, Ph.D.(American College of Clinical Pharmacy), in Doody's Notes Table of ContentsPurity Analysis and Impurities Determination by Reversed-Phase High- Performance Liquid Chromatography. Purity Analysis and Impurities Determination by AEX-HPLC. Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC Analysis. Analysis of Oligonucleotides by Liquid Chromatography—Mass Spectrometry. Sequence Determination and Confirmation by MS/M S and MALDI-TOF. Tm Analysis of Oligonucleotides. Purity and Content Analysis of Oligonucleotides by Capillary Gel Electrophoresis. Bioanalysis of Therapeutic Oligonucleotides Using Hybridization-Based Immunoassay Techniques. Oligonucleotide Assay and Potency. Microbial Analysis: Endotoxin Testing. Analysis of Residual Solvents by Head Space Gas Chromatography. Determination of Extinction Coefficient. Structural Determination by NMR. Infrared Analysis of Oligonucleotides. Stability Indicating Methods for Oligonucleotide Products. Analysis by Hydrophilic Interaction Chromatography. Determination of Base Composition. Analysis of Metals in Oligonucleotides. Regulatory Considerations for the Development of Oligonucleotide Therapeutics.

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Book SynopsisThis introductory text explains both the basic science, production, quality, dosage forms, administration, economic and regulatory aspects and the clinical applications of biotechnology-derived pharmaceuticals. It serves as a complete one-stop source for undergraduate/graduate pharmacists and pharmaceutical science students. An additional important audience are pharmaceutical scientists in industry and academia, particularly those who have not received formal training in pharmaceutical biotechnology and are inexperienced in this field. The rapid growth and advances in the field made it necessary to revise this textbook in order to continue providing up-to-date information and introduce readers to cutting edge knowledge and technology of this field. This Sixth Edition completely updates the previous edition and includes additional coverage on new approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies and vaccines. With more than 3-million-chapter downloads, the fifth edition of the textbook has achieved widespread distribution as a key educational resource for the field of pharmaceutical biotechnology. Table of ContentsMolecular Biotechnology.- Biophysical and biochemical analysis of recombinant proteins.- Production and downstream processing of biotech products.- Formulation of biotech products, including biopharmaceutical considerations.- Pharmacokinetics and pharmacodynamics of peptide and protein drugs.- Immunogenicity of pharmaceutical proteins.- General considerations of monoclonal antibodies from structure to therapeutic application.- Genomics, Other “Omics” Technologies, Personalized Medicine and Additional Biotechnology-Related Techniques.- Dispensing biotechnology products: handling, professional education and product information.- Economic considerations in medical biotechnology.- Regulatory framework for biosimilars.- Vaccines.- Oligonucleotides and siRNA.- Gene therapy.- Stem cell technology.- Therapeutic Applications.-Endocrinology.- Insulin.- Follicle-stimulating hormone.- Growth hormone.- Cardiovascular and Respiratory Applications.- Recombinant coagulation factors and thrombolytics.- Recombinant human deoxyribonuclease.- Oncology.- Monoclonal antibodies in oncology .- Hematopoetic growth factors.- Inflammation and Immunemodulation.- Monoclonal antibodies in transplantation.- Monoclonal antibodies and antibody-based therapeutics in anti-inflammatory therapy.- Interferons and interleukins.- Anti-infectious diseases.- Monoclonal antibodies.- Enzyme replacement therapy.

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Book SynopsisTable of Contents1. Introduction 1.1. Overview 1.2. Drugs Discovered without Rational Design 1.2.1. Medicinal Chemistry Folklore 1.2.2. Discovery of Penicillins 1.2.3. Discovery of Librium 1.2.4. Discovery of Drugs through Metabolism Studies 1.2.5. Discovery of Drugs through Clinical Observations 1.3. Overview of Modern Rational Drug Design 1.3.1. Overview of Drug Targets 1.3.2. Identification and Validation of Targets for Drug Discovery 1.3.3. Alternatives to Target-Based Drug Discovery 1.3.4. Lead Discovery 1.3.5. Lead Modification (Lead Optimization) 1.3.5.1. Potency 1.3.5.2. Selectivity 1.3.5.3. Absorption, Distribution, Metabolism, and Excretion (ADME) 1.3.5.4. Intellectual Property Position 1.3.6. Drug Development 1.3.6.1. Preclinical Development 1.3.6.2. Clinical Development (Human Clinical Trials) 1.3.6.3. Regulatory Approval to Market the Drug 1.4. Epilogue 1.5. General References 1.6. Problems References 2. Lead Discovery and Lead Modification 2.1. Lead Discovery 2.1.1. General Considerations 2.1.2. Sources of Lead Compounds 2.1.2.1. Endogenous Ligands 2.1.2.2. Other Known Ligands 2.1.2.3. Screening of Compounds 2.1.2.3.1. Sources of Compounds for Screening 2.1.2.3.1.1. Natural Products 2.1.2.3.1.2. Medicinal Chemistry Collections and Other "Handcrafted" Compounds 2.1.2.3.1.3. High-Throughput Organic Synthesis 2.1.2.3.1.3.1. Solid-Phase Library Synthesis 2.1.2.3.1.3.2. Solution-Phase Library Synthesis 2.1.2.3.1.3.3. Evolution of HTOS 2.1.2.3.2. Drug-Like, Lead-Like, and Other Desirable Properties of Compounds for Screening 2.1.2.3.3. Random Screening 2.1.2.3.4. Targeted (or Focused) Screening, Virtual Screening, and Computational Methods in Lead Discovery 2.1.2.3.4.1. Virtual Screening Database 2.1.2.3.4.2. Virtual Screening Hypothesis 2.1.2.3.5. Hit-To-Lead Process 2.1.2.3.6. Fragment-based Lead Discovery 2.2. Lead Modification 2.2.1. Identification of the Active Part: The Pharmacophore 2.2.2. Functional Group Modification 2.2.3. Structure–Activity Relationships 2.2.4. Structure Modifications to Increase Potency, Therapeutic Index, and ADME Properties 2.2.4.1. Homologation 2.2.4.2. Chain Branching 2.2.4.3. Bioisosterism 2.2.4.4. Conformational Constraints and Ring-Chain Transformations 2.2.4.5. Peptidomimetics 2.2.5. Structure Modifications to Increase Oral Bioavailability and Membrane Permeability 2.2.5.1. Electronic Effects: The Hammett Equation 2.2.5.2. Lipophilicity Effects 2.2.5.2.1. Importance of Lipophilicity 2.2.5.2.2. Measurement of Lipophilicities 2.2.5.2.3. Computer Automation of log P Determination 2.2.5.2.4. Membrane Lipophilicity 2.2.5.3. Balancing Potency of Ionizable Compounds with Lipophilicity and Oral Bioavailability 2.2.5.4. Properties that Influence Ability to Cross the Blood–Brain Barrier 2.2.5.5. Correlation of Lipophilicity with Promiscuity and Toxicity 2.2.6. Computational Methods in Lead Modification 2.2.6.1. Overview 2.2.6.2. Quantitative Structure–Activity Relationships (QSARs) 2.2.6.2.1. Historical Overview. Steric Effects: The Taft Equation and Other Equations 2.2.6.2.2. Methods Used to Correlate Physicochemical Parameters with Biological Activity 2.2.6.2.2.1. Hansch Analysis: A Linear Multiple Regression Analysis 2.2.6.2.2.2. Manual Stepwise Methods: Topliss Operational Schemes and Others 2.2.6.2.2.3. Batch Selection Methods: Batchwise Topliss Operational Scheme, Cluster Analysis, and Others 2.2.6.2.2.4. Free and Wilson or de Novo Method 2.2.6.2.2.5. Computational Methods for ADME Descriptors 2.2.6.3. Scaffold Hopping 2.2.6.4. Molecular Graphics-Based Lead Modification 2.2.7. Epilogue 2.3. General References 2.4. Problems References 3. Receptors 3.1. Introduction 3.2. Drug–Receptor Interactions 3.2.1. General Considerations 3.2.2. Important Interactions (Forces) Involved in the Drug–Receptor Complex 3.2.2.1. Covalent Bonds 3.2.2.2. Ionic (or Electrostatic) Interactions 3.2.2.3. Ion–Dipole and Dipole–Dipole Interactions 3.2.2.4. Hydrogen Bonds 3.2.2.5. Charge–Transfer Complexes 3.2.2.6. Hydrophobic Interactions 3.2.2.7. Cation–p Interaction 3.2.2.8. Halogen Bonding 3.2.2.9. van der Waals or London Dispersion Forces 3.2.2.10. Conclusion 3.2.3. Determination of Drug–Receptor Interactions 3.2.4. Theories for Drug–Receptor Interactions 3.2.4.1. Occupancy Theory 3.2.4.2. Rate Theory 3.2.4.3. Induced-Fit Theory 3.2.4.4. Macromolecular Perturbation Theory 3.2.4.5. Activation–Aggregation Theory 3.2.4.6. The Two-State (Multistate) Model of Receptor Activation 3.2.5. Topographical and Stereochemical Considerations 3.2.5.1. Spatial Arrangement of Atoms 3.2.5.2. Drug and Receptor Chirality 3.2.5.3. Diastereomers 3.2.5.4. Conformational Isomers 3.2.5.5. Atropisomers 3.2.5.6. Ring Topology 3.2.6. Case History of the Pharmacodynamically Driven Design of a Receptor Antagonist: Cimetidine 3.2.7. Case History of the Pharmacokinetically Driven Design of Suvorexant 3.3. General References 3.4. Problems References 4. Enzymes 4.1. Enzymes as Catalysts 4.1.1. What are Enzymes? 4.1.2. How do Enzymes Work? 4.1.2.1. Specificity of Enzyme-Catalyzed Reactions 4.1.2.1.1. Binding Specificity 4.1.2.1.2. Reaction Specificity 4.1.2.2. Rate Acceleration 4.2. Mechanisms of Enzyme Catalysis 4.2.1. Approximation 4.2.2. Covalent Catalysis 4.2.3. General Acid–Base Catalysis 4.2.4. Electrostatic Catalysis 4.2.5. Desolvation 4.2.6. Strain or Distortion 4.2.7. Example of the Mechanisms of Enzyme Catalysis 4.3. Coenzyme Catalysis 4.3.1. Pyridoxal 5'-Phosphate 4.3.1.1. Racemases 4.3.1.2. Decarboxylases 4.3.1.3. Aminotransferases (Formerly Transaminases) 4.3.1.4. PLP-Dependent ß-Elimination 4.3.2. Tetrahydrofolate and Pyridine Nucleotides 4.3.3. Flavin 4.3.3.1. Two-Electron (Carbanion) Mechanism 4.3.3.2. Carbanion Followed by Two One-Electron Transfers 4.3.3.3. One-Electron Mechanism 4.3.3.4. Hydride Mechanism 4.3.4. Heme 4.3.5. Adenosine Triphosphate and Coenzyme A 4.4. Enzyme Catalysis in Drug Discovery 4.4.1. Enzymatic Synthesis of Chiral Drug Intermediates 4.4.2. Enzyme Therapy 4.5. General References 4.6. Problems References 5. Enzyme Inhibition and Inactivation 5.1. Why Inhibit an Enzyme? 5.2. Reversible Enzyme Inhibitors 5.2.1. Mechanism of Reversible Inhibition 5.2.2. Selected Examples of Competitive Reversible Inhibitor Drugs 5.2.2.1. Simple Competitive Inhibition 5.2.2.1.1. Epidermal Growth Factor Receptor Tyrosine Kinase as a Target for Cancer 5.2.2.1.2. Discovery and Optimization of EGFR Inhibitors 5.2.2.2. Stabilization of an Inactive Conformation: Imatinib, an Antileukemia Drug 5.2.2.2.1. The Target: Bcr-Abl, a Constitutively Active Kinase 5.2.2.2.2. Lead Discovery and Modification 5.2.2.2.3. Binding Mode of Imatinib to Abl Kinase 5.2.2.2.4. Inhibition of Other Kinases by Imatinib 5.2.2.3. Alternative Substrate Inhibition: Sulfonamide Antibacterial Agents (Sulfa Drugs) 5.2.2.3.1. Lead Discovery 5.2.2.3.2. Lead Modification 5.2.2.3.3. Mechanism of Action 5.2.3. Transition State Analogs and Multisubstrate Analogs 5.2.3.1. Theoretical Basis 5.2.3.2. Transition State Analogs 5.2.3.2.1. Enalaprilat 5.2.3.2.2. Pentostatin 5.2.3.2.3. Forodesine and DADMe-ImmH 5.2.3.2.4. Multisubstrate Analogs 5.2.4. Slow, T ight-Binding Inhibitors 5.2.4.1. Theoretical Basis 5.2.4.2. Captopril, Enalapril, Lisinopril, and Other Antihypertensive Drugs 5.2.4.2.1. Humoral Mechanism for Hypertension 5.2.4.2.2. Lead Discovery 5.2.4.2.3. Lead Modification and Mechanism of Action 5.2.4.2.4. Dual-Acting Drugs: Dual-Acting Enzyme Inhibitors 5.2.4.3. Lovastatin (Mevinolin) and Simvastatin, Antihypercholesterolemic Drugs 5.2.4.3.1. Cholesterol and Its Effects 5.2.4.3.2. Lead Discovery 5.2.4.3.3. Mechanism of Action 5.2.4.3.4. Lead Modification 5.2.4.4. Saxagliptin, a Dipeptidyl Peptidase-4 Inhibitor and Antidiabetes Drug 5.2.5. Case History of Rational Drug Design of an Enzyme Inhibitor: Ritonavir 5.2.5.1. Lead Discovery 5.2.5.2. Lead Modification 5.3. Irreversible Enzyme Inhibitors 5.3.1. Potential of Irreversible Inhibition 5.3.2. Affinity Labeling Agents 5.3.2.1. Mechanism of Action 5.3.2.2. Selected Affinity Labeling Agents 5.3.2.2.1. Penicillins and Cephalosporins/Cephamycins 5.3.2.2.2. Aspirin 5.3.3. Mechanism-Based Enzyme Inactivators 5.3.3.1. Theoretical Aspects 5.3.3.2. Potential Advantages in Drug Design Relative to Affinity Labeling Agents 5.3.3.3. Selected Examples of Mechanism-Based Enzyme Inactivators 5.3.3.3.1. Vigabatrin, an Anticonvulsant Drug 5.3.3.3.2. Eflornithine, an Antiprotozoal Drug and Beyond 5.3.3.3.3. Tranylcypromine, an Antidepressant Drug 5.3.3.3.4. Selegiline (l-Deprenyl) and Rasagiline: Antiparkinsonian Drugs 5.3.3.3.5. 5-Fluoro-2'-deoxyuridylate, Floxuridine, and 5-Fluorouracil: Antitumor Drugs 5.4. General References 5.5. Problems References 6. DNA-Interactive Agents 6.1. Introduction 6.1.1. Basis for DNA-Interactive Drugs 6.1.2. Toxicity of DNA-Interactive Drugs 6.1.3. Combination Chemotherapy 6.1.4. Drug Interactions 6.1.5. Drug Resistance 6.2. DNA Structure and Properties 6.2.1. Basis for the Structure of DNA 6.2.2. Base Tautomerization 6.2.3. DNA Shapes 6.2.4. DNA Conformations 6.3. Classes of Drugs that Interact with DNA 6.3.1. Reversible DNA Binders 6.3.1.1. External Electrostatic Binding 6.3.1.2. Groove Binding 6.3.1.3. Intercalation and Topoisomerase-Induced DNA Damage 6.3.1.3.1. Amsacrine, an Acridine Analog 6.3.1.3.2. Dactinomycin, the Parent Actinomycin Analog 6.3.1.3.3. Doxorubicin (Adriamycin) and Daunorubicin (Daunomycin), Anthracycline Antitumor Antibiotics 6.3.1.3.4. Bis-intercalating Agents 6.3.2. DNA Alkylators 6.3.2.1. Nitrogen Mustards 6.3.2.1.1. Lead Discovery 6.3.2.1.2. Chemistry of Alkylating Agents 6.3.2.1.3. Lead Modification 6.3.2.2. Ethylenimines 6.3.2.3. Methanesulfonates 6.3.2.4. (+)-CC-1065 and Duocarmycins 6.3.2.5. Metabolically Activated Alkylating Agents 6.3.2.5.1. Nitrosoureas 6.3.2.5.2. Triazene Antitumor Drugs 6.3.2.5.3. Mitomycin C 6.3.2.5.4. Leinamycin 6.3.3. DNA Strand Breakers 6.3.3.1. Anthracycline Antitumor Antibiotics 6.3.3.2. Bleomycin 6.3.3.3. Tirapazamine 6.3.3.4. Enediyne Antitumor Antibiotics 6.3.3.4.1. Esperamicins and Calicheamicins 6.3.3.4.2. Dynemicin A 6.3.3.4.3. Neocarzinostatin (Zinostatin) 6.3.3.5. Sequence Specificity for DNA-Strand Scission 6.4. General References 6.5. Problems References 7. Drug Resistance and Drug Synergism 7.1. Drug Resistance 7.1.1. What is Drug Resistance? 7.1.2. Mechanisms of Drug Resistance 7.1.2.1. Altered Target Enzyme or Receptor 7.1.2.2. Overproduction of the Target Enzyme or Receptor 7.1.2.3. Overproduction of the Substrate or Ligand for the Target Protein 7.1.2.4. Increased Drug-Destroying Mechanisms 7.1.2.5. Decreased Prodrug-Activating Mechanism 7.1.2.6. Activation of New Pathways Circumventing the Drug Effect 7.1.2.7. Reversal of Drug Action 7.1.2.8. Altered Drug Distribution to the Site of Action 7.2. Drug Synergism (Drug Combination) 7.2.1. What is Drug Synergism? 7.2.2. Mechanisms of Drug Synergism 7.2.2.1. Inhibition of a Drug-Destroying Enzyme 7.2.2.2. Sequential Blocking 7.2.2.3. Inhibition of Targets in Different Pathways 7.2.2.4. Efflux Pump Inhibitors 7.2.2.5. Use of Multiple Drugs for the Same Target 7.3. General References 7.4. Problems References 8. Drug Metabolism 8.1. Introduction 8.2. Synthesis of Radioactive Compounds 8.3. Analytical Methods in Drug Metabolism 8.3.1. Sample Preparation 8.3.2. Separation 8.3.3. Identification 8.3.4. Quantification 8.4. Pathways for Drug Deactivation and Elimination 8.4.1. Introduction 8.4.2. Phase I Transformations 8.4.2.1. Oxidative Reactions 8.4.2.1.1. Aromatic Hydroxylation 8.4.2.1.2. Alkene Epoxidation 8.4.2.1.3. Oxidations of Carbons Adjacent to sp2 Centers 8.4.2.1.4. Oxidation at Aliphatic and Alicyclic Carbon Atoms 8.4.2.1.5. Oxidations of Carbon–Nitrogen Systems 8.4.2.1.6. Oxidations of Carbon–Oxygen Systems 8.4.2.1.7. Oxidations of Carbon–Sulfur Systems 8.4.2.1.8. Other Oxidative Reactions 8.4.2.1.9. Alcohol and Aldehyde Oxidations 8.4.2.2. Reductive Reactions 8.4.2.2.1. Carbonyl Reduction 8.4.2.2.2. Nitro Reduction 8.4.2.2.3. Azo Reduction 8.4.2.2.4. Azido Reduction 8.4.2.2.5. Tertiary Amine Oxide Reduction 8.4.2.2.6. Reductive Dehalogenation 8.4.2.3. Carboxylation Reaction 8.4.2.4. Hydrolytic Reactions 8.4.3. Phase II Transformations: Conjugation Reaction 8.4.3.1. Introduction 8.4.3.2. Glucuronic Acid Conjugation 8.4.3.3. Sulfate Conjugation 8.4.3.4. Amino Acid Conjugation 8.4.3.5. Glutathione Conjugation 8.4.3.6. Water Conjugation 8.4.3.7. Acetyl Conjugation 8.4.3.8. Fatty Acid and Cholesterol Conjugation 8.4.3.9. Methyl Conjugation 8.4.4. Toxicophores and Reactive Metabolites (RMs) 8.4.5. Hard and Soft (Antedrugs) Drugs 8.5. General References 8.6. Problems References 9. Prodrugs and Drug Delivery Systems 9.1. Enzyme Activation of Drugs 9.1.1. Utility of Prodrugs 9.1.1.1. Aqueous Solubility 9.1.1.2. Absorption and Distribution 9.1.1.3. Site Specificity 9.1.1.4. Instability 9.1.1.5. Prolonged Release 9.1.1.6. Toxicity 9.1.1.7. Poor Patient Acceptability 9.1.1.8. Formulation Problems 9.1.2. Types of Prodrugs 9.2. Mechanisms of Drug Inactivation 9.2.1. Carrier-Linked Prodrugs 9.2.1.1. Carrier Linkages for Various Functional Groups 9.2.1.1.1. Alcohols, Carboxylic Acids, and Related 9.2.1.1.2. Amines and Amidines 9.2.1.1.3. Sulfonamides 9.2.1.1.4. Carbonyl Compounds 9.2.1.2. Examples of Carrier-Linked Bipartite Prodrugs 9.2.1.2.1. Prodrugs for Increased Water Solubility 9.2.1.2.2. Prodrugs for Improved Absorption and Distribution 9.2.1.2.3. Prodrugs for Site Specificity 9.2.1.2.4. Prodrugs for Stability 9.2.1.2.5. Prodrugs for Slow and Prolonged Release 9.2.1.2.6. Prodrugs to Minimize Toxicity 9.2.1.2.7. Prodrugs to Encourage Patient Acceptance 9.2.1.2.8. Prodrugs to Eliminate Formulation Problems 9.2.1.3. Macromolecular Drug Carrier Systems 9.2.1.3.1. General Strategy 9.2.1.3.2. Synthetic Polymers 9.2.1.3.3. Poly(a-Amino Acids) 9.2.1.3.4. Other Macromolecular Supports 9.2.1.4. Tripartite Prodrugs 9.2.1.5. Mutual Prodrugs (also called Codrugs) 9.2.2. Bioprecursor Prodrugs 9.2.2.1. Origins 9.2.2.2. Proton Activation: An Abbreviated Case History of the Discovery of Omeprazole 9.2.2.3. Hydrolytic Activation 9.2.2.4. Elimination Activation 9.2.2.5. Oxidative Activation 9.2.2.5.1. N- and O-Dealkylations 9.2.2.5.2. Oxidative Deamination 9.2.2.5.3. N-Oxidation 9.2.2.5.4. S-Oxidation 9.2.2.5.5. Aromatic Hydroxylation 9.2.2.5.6. Other Oxidations 9.2.2.6. Reductive Activation 9.2.2.6.5. Nitro Reduction 9.2.2.7. Nucleotide Activation 9.2.2.8. Phosphorylation Activation 9.2.2.9. Sulfation Activation 9.2.2.10. Decarboxylation Activation 9.3. General References 9.4. Problems References Appendix Index

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Book SynopsisTable of Contents1. Introduction 2. Polysorbate Surfactants used in biopharmaceuticals: An overview including in vivo fate and toxicology perspective 3. Surfactants (polysorbate and poloxamer) synthesis and degradation: Overview and relevance 4. Mechanisms of stabilization of proteins by surfactants 5. Behaviour of surfactant during processing (UF/DF, filter adsorption) 6. Analytical methods for surfactant characterization in Drug Product 7. Oxidative degradation of surfactants: Mechanisms 8. Hydrolytic degradation of surfactants and impact on protein stabilization 9. Regulatory Perspective on Surfactant Monitoring and Control 10. Control strategies to address surfactant degradation: A quality perspective 11. A look to the future - closing remarks

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Book SynopsisDrug Design and Development outlines the processes involved in the design and development of new drugs and emphasises the significance of these processes to the practice of pharmacy. The book highlights why it is important that all practicing pharmacists, including those working in hospitals or high street stores, have a solid understanding of the process of the design and development of the drugs they interact with. It adopts an integrated approach, formulated to complement courses which are designed in line with the General Pharmaceutical Council''s new curriculum requirements. Furthermore, this is the only integrated textbook to consider both drug design and development within one volume. Throughout the book, the journey of the drug, from discovery to market, is presented in an integrated fashion, emphasising the interconnection of all the processes involved.Trade ReviewWell written text that guides students through the complex elements of the drug development process. It has a chemistry focus and utilises 'key points' to reinforce the important aspects at regular opportunities. * Dr James F. Brown, University of Portsmouth *Table of Contents1: Introduction Part 1 Drug targets 2: Receptors and signal transduction 3: Enzymes as drug targets 4: Nucleic acids and protein synthesis as drug targets 5: Other drug targets Part 2 Origins of drug molecules 6: Sources of lead compounds 7: Drug synthesis 8: Optimisation of lead compounds 9: Computer-aided drug design 10: Combinatorial chemistry and high-throughput screening 11: Biotechnology and biopharmaceuticals Part 3 Biological aspects of drug development 12: Drug metabolism 13: Pharmacogenetics and pharmacogenomics 14: Toxicity testing Part 4 Preformulation studies 15: Solubility and drug development 16: Solid state characteristics 17: Drug stability Part 5 Clinical research 18: Clinical research and its regulation 19: Design and management of clinical trials

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Book SynopsisMicrobiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methTable of ContentsSafety in Microbiology. Culture Media. Sampling. Enumeration of Micro-organisms. Identification of Micro-organisms. Specified Organisms. Rapid Methods. Sterility Assurance. Endotoxin Testing. Preservative Efficacy Testing. Microbiological Assay. Disinfection and Cleansing. Microbiological Audit. Case Studies and Calculations.

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Book SynopsisFocusing on the management of healthcare related biotechnology, this text is a practical guide assisting all healthcare related biotech professionals in their day-to-day activities. It contains chapters on bioeconomy, biolicensing, biofinance, biopartnering, biodrug research, biomarket planning, biopromotion, product life cycle management, and bTable of ContentsThe Healthcare Biotechnology Industry: Bioeconomy. Intellectual Property: Intellectual Property Management. Biolicensing. Funding: Biofinance. Biopartnering. New Product Development: Biodrug Research. Biomanufacturing. Marketing: Biomarketing planning. Biopromotion. Biopricing. Biosupply Chain. Product Life Cycle Management. Running the Business: Biobusiness models. Biosimilars Model. Biocompany Life Cycle.

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a huge range and FREE tracked UK delivery on ALL orders.

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Book SynopsisThere is a dramatic rise of novel drug use due to the increased popularity of so-called designer drugs. These synthetic drugs can be illegal in some countries, but legal in others and novel compounds unknown to drug chemistry emerge monthly. This thoughtfully constructed edited reference presents the main chromatographic methodologies and strategies used to discover and analyze novel designer drugs contained in diverse biological materials. The methods are based on molecular characteristics of the drugs belonging to each individual class of compounds, so it will be clear how the current methods are adaptable to future new drugs that appear in the market.Table of ContentsIntroduction. Designer Drugs: Legislating for Tomorrow Through the Use of Class Definitions and Pharmacophore Principles. Alternative Legislation with Designer Drugs. Biological Precursors of Designer Drugs. Liquid Chromatography – Mass Spectrometry in Analysis of Designer Drugs. Ambient Plasma Ionization Techniques in Forensic Analysis. Application of LC-QTOFMS for the Identification of the Structure of New Psychoactive Substances. Rapid Generation of Metabolites by Electrochemical Method. Gas Chromatography – Mass Spectrometry in Analysis of Designer Drugs. NMR Spectroscopy in the Analysis of Designer Drugs. Preparation of Biological Material for Toxicological Analysis. Discrimination among the Designer Drug Isomers by Chromatographic and Spectrometric Methods. Liquid Chromatography-Mass Spectrometry and Ambient Mass Spectrometry Applied to the Analysis of Synthetic Cannabinoids. Cathinone Derivatives and Their Analysis. NBOMe Derivatives of Phenylethylamines and Their Analysis. 2C Derivatives of Phenylethylamines and Their Analysis. Modern Techniques for the Analysis of Piperazines. Fenantyl Analogues and Their Analysis. Modern Techniques for the Identification of Tryptamines. Toxicological Analysis of New Opioids. Toxicological Analysis of Designer Benzodiazepines. Thin-layer Chromatography in the Analysis of Designer Drugs

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Book SynopsisRevised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles tTable of Contents1. Why Validation?, 2. Facility Design for Validation, 3. Modular Facilities – Meeting the Need for Flexibility, 4. Commissioning and Qualification, 5. Design & Quaification of Controlled Environments, 6. Validation of Pharmaceutical Water Systems, 7. Validation of Critical Utilities, 8. Calibration and Metrology, 9. Risk Management and Thermal Validation, 10. Change Control, 11. MICROBIOLOGY OF STERILIZATION PROCESSES, 12. Biological Indicators, 13. Steam Sterilization in Autoclaves, 14. Validation of Terminal Sterilization, 15. Steam Sterilization-in-Place Technology and Validation, 16. Dry Heat Sterilization, 17. Depyrogenation by Inactivation and Removal, 18. Ethylene Oxide Sterilization, 19. Validation of chlorine dioxide Sterilization, 20. Liquid Phase Sterilization, 21. Vapor Sterilization and Decontamination, 22. Validation of the Radiation Sterilization of Pharmaceuticals, 23. Validation of Sterilizing Grade Filters, 24. Disinfecting Agents: The Art of Disinfection, 25. Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods, 26. Contamination Control for Component Introduction to Classified Areas, 27. Aseptic Processing for Dosage Form Manufacture, 28. Validation of Manual Aseptic Processes, 29. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals, 30. Qualification and Validation of Advanced Aseptic Processing Technologies, 31. Total Particle Monitoring, 32. Environmental Monitoring, 33. Validation of Container Component Preparation, 34. Validation of Lyophilization, 35. Validation of Packaging Processes for Sterile Products, 36. Validation of Active Pharmaceutical Ingredients, 37. Cell Culture Process Validation including Cell Bank Qualification, 38. Validation of Recovery and Purification Processes, 39. Validation of Process Chromatography, 40. Single Use Technologies and Systems, 41. Considerations for Process Validation for Cell and Gene Therapies, 42. Validation of Solid Dosage Forms, 43. Validation of Validation of Oral / Topical Liquids & Semi-Solids, 44. Validation of Non-Sterile Packaging Operations, 45. Validation of Cleaning Processes, 46. Validation of Training, 47. Vendor Qualification and Validation, 48. Validation of Clinical Trial Manufacturing, 49. Validation of New Products, 50. Retrospective / Continuous Process Validation, 51. Validation & 6 Sigma, 52. Validation and Contract Manufacturing, 53. Computerized Systems Validation, 54. Risk Based Validation of Laboratory Information Management Systems, 55. Control Systems Validation, 56. Process Analytical Technology and Validation, 57. Validation of Analytical Procedures and Physical Methods, 58. Validation of Microbial Methods, 59. "Rapid Methods for Aseptic Processing and Their Validation", 60. Extractables and Leachables in Drug Products: An Overview, 61. Evolution and Implementation of Validation in the United States, 62. Validation in Europe - What are the Differences?, 63. Japanese Approach to Validation, 64. Organization of Validation in a MultiNational Pharmaceutical Company, 65. Validation in a Small Pharmaceutical Company, 66. Regulatory Aspects of Process Validation in the United States, 67. The Future of Validation

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Book SynopsisWhat defines a quality lead, where these quality leads come from and how one discovers them has been the subject of intense debate within the pharmaceutical industry. This volume addresses these questions and discusses diabetes, obesity and tuberculosis. It presents research in the field of drug discovery.Table of ContentsPreface List of Contributors Hit and Lead Identification: Efficient practices for drug discovery DPPIV Inhibition: Promising Therapy for the Treatment of Type 2 Diabetes Recent Progress Towards Nonpeptide Ligands for the Melanocortin-4 Receptor Tuberculosis chemotherapy: recent developments and future perspectives Subject Index Author Index (Volumes 1-45) Subject Index (Volumes 1-45)

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Book SynopsisThe drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery.Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.Trade Review“The book comprises of 10 well-defined chapters. Detailed discussion on historical background to drug discovery in modern age consists of basic concepts, how they have evolved and various approaches and strategies in modern drug discovery. … The book provides a very good review on all aspects of industrialization of drug discovery. … the book is of particular interest since it gives a systematic and in depth account of related topics to transform research into industrialization. This is a very good book of relevance to anyone interested in drug discovery and more, so for all personnel working in drug discovery.” —K. S. Laddha, Reader in Pharmacognosy, University Institute of Chemical Technology, Mumbai, in Chemical Industry Digest, February 2007"Chapter 4, the best part of the book, is an extensive and excellent discussion of aspects of compound- library management. The authors of this chapter have considered all basic aspects of this important component of drug discovery . . . well written with extensive references." – Robert Goodnow, Hoffmann-LaRoche, in ChemMedChem, 2006, No. 3Table of ContentsDrug Discovery in the Modern Age: How We Got Here and Where Do We Go?. The Regulatory Age. Industrialization Not Automation. Compound Management. High Throughput Screening. Parallel Lead Optimization. Knowledge Management. ROI – How to Measure It? How to Get It?. Collaboration in a Virtual and Global Environment. From Genome to Drug: Ethical Issues.

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Book SynopsisSetting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis.The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.Trade Review"…provides the reader with a pragmatic approach to the principles governing accepted methodologies within the working environment and provides some useful examples of these interpretational differences across industry."-Quasar"…provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations."--Anticancer ResearchTable of ContentsIn the Beginning There Was GLP. Before GCP. Training in the Regulated Environment. Computing in the Regulated Environment. QA Activity. Beyond Compliance. Business Improvement. A Summary. Appendix: Information Resources and Acronyms.

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Book SynopsisThe use of medicinal plants in herbal and modern medicine has gained popularity over the last few decades due to consumers taking more natural approaches to medicine. Aquatic medicinal plants are rich in bioactive compounds and demonstrate various commercial, nutraceutical, and biological applications. Aquatic Medicinal Plants offers the reader a wealth of information on uses of bioactive components of these plants, along with crucial references, and explains their traditional uses, phytochemistry, and pharmacological properties.Features Provides information on aquatic and semiaquatic medicinal plants and their uses globally. Discusses phytochemical components with the known active constituents and their pharmaceutical applications. This volume in the Exploring Medicinal Plants series is appropriate for scientists, experts, and consultants associated with the exploration of aquatic medicinal plant usage.  This book is an essenTable of ContentsMedicinal Importance of Nelumbo nucifera. Traditional Uses, Important Phytochemical, and Therapeutic Profile of Persicaria hydropiper. Ethnobotanical, Phytochemistry, and Pharmacological Activity of Marsilea minuta. Traditional Uses, Phytochemistry, and Pharmacological Properties of Hedychium coronarium. Pharmacognostical Phytochemical, and Ethnomedicinal Properties of Enhydra fluctuans. Medicinal Uses and Pharmacological Properties of Acorus calamus. Medicinal properties of Rotula aquatic. Traditional Uses and Pharmacological Profile of Sphaeranthus indicus. Phytochemistry and Medicinal Uses of Pistia stratiotes. Biological Activity and Medicinal Uses of Arundo donax. Sagittaria sagittifolia. Phytochemistry and Pharmaceutical Application of Laurencia obtuse: A Red Seaweed. Phytochemical and Therapeutic Properties of Didemnum genus. Brown Algae (Phaeophyta) Source of Different Phytochemical and their Medicinal Application. Phytochemistry and Bioactivity of Green Algae (Chlorophyta). Chemical Composition and Biological Activity of Red Algae (Rhodophyta).

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Book SynopsisCombination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), âœa combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.â Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices.This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI â Association for the Advancement of Medical Instrumentation.

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Book SynopsisThis volume in the popular series, Drugs and the Pharmaceutical Sciences, begins with the history of cancer treatment, carcinogens, and molecular mechanisms involved in cancer pathogenesis. It incudes conventional and advanced cancer therapies ranging from oral and parenteral preparations to advanced fabricated systems such as nanoparticles, liposomes, antibodies, aptamers, poly(amidoamine) and photodynamic therapies. The preparation and mechanisms of molecular targeting of cancer are presented and the authors focus on a diverse audience including undergraduates and research students.Features Timely coverage of changes in process control technology for the phamaceutical industry, a dynamic area in terms of products and manufacturing processes Provides an update on the unique requirements of these industries and how they differ from others, for example the microelectronics or specialized chemicals industries Draws on the author''s vaTable of Contents History of Cancer Therapies Cancer and Carcinogens Causes of Death from Cancer Passive Targeting Cancer Active Targeting Strategies Conventional Cancer Therapies Oral Anticancer Therapies Parenteral Anticancer Therapies Advanced Cancer Therapies The Advent of Micro and Nano-spheres for Cancer Treatment The Emergence of Liposomes in Cancer Therapy Niosomes-Based Anticancer Therapies Solid Lipid Nanoparticles-Based Anticancer Therapies Mesoporous Nanoparticles-Based Anticancer Therapies Antibody-Based Cancer Therapies Aptamer-Based Anticancer Therapies Polyamidoamines-Based Anticancer Therapies Photodynamic Therapies for Cancer Treatment

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Book SynopsisMedical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles.Features:Defines the purpose and value of Medical Affairs and provides clear career Table of ContentsSECTION 1: MEDICAL AFFAIRS IN THE PHARMACEUTICAL AND MEDTECH INDUSTRIES Chapter 1 What Is Medical Affairs? Chapter 2 Groups and Structure of Medical Affairs Chapter 3 Medical Affairs Collaborations Across the Drug/Device Development Lifecycle Chapter 4 Measuring the Impact of Medical Affairs Chapter 5 Medical Affairs Careers SECTION 2: THE PRACTICE OF MEDICAL AFFAIRS Chapter 6 Medical Strategy and Launch Excellence Chapter 7 Evidence Generation and Real-World Evidence Chapter 8 Medical Communications Chapter 9 External Education Chapter 10 Field Medical Chapter 11 Insights Chapter 12 Medical Information Chapter 13 Patient Centricity Chapter 14 Medical Operations Chapter 15 Digital Strategy Chapter 16 Compliance Chapter 17 Rare Disease and Gene Therapy Chapter 18 Medical Affairs in MedTech

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Book SynopsisThe management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers.Features:Provides an introduction and background information for the spectrum of clinical data management tasks.                            &nbsp

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Book SynopsisLeadership in the Pharmaceutical Industry focuses on leadership in pharmaceutical organisations at three levels: individual, team, and organisational. At the individual level, it covers leadership basics, theories, types of leaders, differences between leader and manager, leadership traits and skills, and systems thinking. At the team level, it explores leadership styles, the leader's interaction with the team, and employee motivation, including the use of intrinsic motivational factors. At the organisational level, it examines the leader's role in creating and maintaining organisational culture, forming and implementing organisational strategy, and managing organisational changes.The book also addresses the specifics of the pharmaceutical industry, including the types and characteristics of innovations and the ethics of leader behaviour, emphasising the importance of ethical leadership. Notably, leadership issues are illustrated with practical cases featuring prominent leaders such as Paul Janssen, Daniel Vasella, Charles Walgreen III, John C. Martin, Roy Vagelos, Albert Bourla, Kiran Mazumdar-Shaw, and Filya Zhebrovska. These leaders were or are involved in creating, manufacturing, and providing patients with pharmaceutical products.The book is designed to benefit readers from various business sectors, with the primary audience being academics, students, and individuals interested in leadership in the pharmaceutical industry.

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Book SynopsisBioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to thTable of ContentsPreface viiXiaohui Xu and Weifeng Xu Foreword ixBinodh DeSilva Acknowledgments xiii About the Editors xv List of Contributors xvii 1 Overview of the Development of Biotherapeutics and the Role of Bioanalytical Sciences 1Robert Dodge 2 Basic Immunology for Bioanalytical Testing of Biotherapeutics 23Kang Chen and Weifeng Xu 3 Platform and Instrument Considerations in Bioanalytical Testing 51Dominic Warrino and Franklin Spriggs 4 Pharmacokinetic Assays 67Tong-Yuan Yang and Eric Wakshull 5 Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment 87Yan G. Ni, Lindsay E. King and Carmen Fernández-Metzler 6 Immunogenicity Risk Assessment for Biotherapeutics 141Jochem Gokemeijer 7 Bioanalytical Strategy to Support Clinical Immunogenicity Assessment: Anti-drug Antibodies 159Ying Wang and Michael Luong 8 Bioanalytical Scheme for Antidrug Neutralizing Antibody Assays 185Weifeng Xu, Bonnie Wu and Jim McNally 9 Critical Reagents in Bioanalysis 209Yang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek 10 Statistical Aspects of Bioanalytical Testing 239Arkady M. Gershteyn and Mark Ma 11 Bioanalytical Aspects in Biological Therapeutics: Biotransformation 277Wenying Jian, Cong Wei and Jinping Gan 12 New Modalities: Multidomain Therapeutics and Gene Therapy Programs 309Kelly Colletti and Mark Ma 13 Regulatory Aspects for Assay Development, Validation, and Sample Analysis 327Amy Lavelle and Megan Wiberg Index 355

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Book SynopsisTopical and transdermal drug delivery systems (TDDs) have several advantages over traditional drug delivery methods, as they can be less invasive, more sanitary, more cost-effective, and may result in better patient compliance. TDDs play a significant role in therapeutics with a variety of preparations and approaches designed by expert formulation scientists. This volume integrates a wide variety of case studies, research, and theories to reveal their diversity and capture the novel approaches of transdermal and topical drug delivery employed by developers and content experts in the field. It provides an abundance of important information and state-of-the-art research on topical and transdermal drug delivery systems and addresses the basics of drug delivery systems, strategies to enhance permeation across membranes, and formulation and evaluation of diverse dosage forms.The volume presents an evaluation of the pros and cons of conventional drug delivery systems against TDDs and discusses the nuances of micro- and nano-systems in TDDs. The extraordinary packages of nano systems (vesicular systems, polymeric nanoparticles, nanoemulsion and dendrimers) are broadly discussed, and their applications are reviewed through a transdermal route.The book looks at TDDs and the main nanoparticles used in skin diseases and lesions of the aging, such as psoriasis, vitiligo, cancer, lesions of the aging and others. Chapters also discuss polymeric micelles in topical and transdermal delivery; microneedles; emulsion, nanoemulsion and microemulsion; TDDs in pulmonary drug delivery systems; nanoencapsulated nasal drug delivery systems; skin sensitivity and irritation testing for transposing transdermal drug delivery systems; and regulatory aspects of drug development for dermal products.Topical and Transdermal Drug Delivery Systems: Applications and Prospects will be a valuable resource for pharmaceutical scientists and researchers, industry professionals, and academicians and students of the pharmaceutical and biomedical sciences.Table of ContentsPART I: BASICS OF TRANSDERMAL DRUG DELIVERY SYSTEMS 1. Concepts and Applications in Topical and Transdermal Drug Delivery 2. Micro- and Nano-Systems in Transdermal Drug Delivery System 3. Advanced Topical and Transdermal Drug Delivery (TTDS) Used in Skin Diseases and Lesions of the Aging PART II: DIVERSE TRANSDERMAL DRUG DELIVERY SYSTEMS 4. Polymeric Micelles in Topical and Transdermal Delivery 5. Microneedles: An Innovative Strategy for Skin Drug Delivery, Diagnostic, and Cosmetologic Approaches 6. Emulsion, Nanoemulsion, and Microemulsion in Tdds 7. Pulmonary Drug Delivery Systems 8. Nanoencapsulated Nasal Drug Delivery System PART III: MISCELLANEOUS 9. Skin Sensitivity and Irritation Testing for Transposing Transdermal Drug Delivery System 10. Regulatory Aspects of Drug Development for Dermal Products

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Book SynopsisHigh throughput screening remains a key part of early stage drug and tool compound discovery, and methods and technologies have seen many fundamental improvements and innovations over the past 20 years. This comprehensive book provides a historical survey of the field up to the current state-of-the-art. In addition to the specific methods, this book also considers cultural and organizational questions that represent opportunities for future success. Following thought-provoking foreword and introduction from Professor Stuart Schreiber and the editors, chapters from leading experts across academia and industry cover initial considerations for screening, methods appropriate for different goals in small molecule discovery, newer technologies that provide alternative approaches to traditional miniaturization procedures, and practical aspects such as cost and resourcing. Within the context of their historical development, authors explain common pitfalls and their solutions. This book will serve as both a practical reference and a thoughtful guide to the philosophy underlying technological change in such a fast-moving area for postgraduates and researchers in academia and industry, particularly in the areas of chemical biology, pharmacology, structural biology and assay development.Table of ContentsPerspective/overview: State of the art in HTS at the academic-industry interface; Assay design and optimization; Assessment of available compound collections; Novel approaches to discovery and analysis of interesting compound combinations; Modern biophysical methods in target-based screening; Genetic perturbation methods; Understanding luminescence-based screens; Measuring interactions in live cells; Approaches to high-content imaging and multi-feature analysis; Profiling of genetically characterized cell systems; Multidimensional profile-based screening; Using biological systems that better recapitulate physiology; Phenotypic screens with model organisms; Encoded libraries; Modern virtual screening; Research data management; Small molecule bioactivity databases; Chemical biology in a pharma environment; Practical aspects of funding and executing high-throughput screens;

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Book SynopsisComputational Drug Discovery A comprehensive resource that explains a wide array of computational technologies and methods driving innovation in drug discovery Computational Drug Discovery: Methods and Applications (2 volume set) covers a wide range of cutting-edge computational technologies and computational chemistry methods that are transforming drug discovery. The book delves into recent advances, particularly focusing on artificial intelligence (AI) and its application for protein structure prediction, AI-enabled virtual screening, and generative modeling for compound design. Additionally, it covers key technological advancements in computing such as quantum and cloud computing that are driving innovations in drug discovery. Furthermore, dedicated chapters that addresses the recent trends in the field of computer aided drug design, including ultra-large-scale virtual screening for hit identification, computational strategies for designing new therapeutic modalities like PROTACs and covalent inhibitors that target residues beyond cysteine are also presented. To offer the most up-to-date information on computational methods utilized in Computational Drug Discovery, it covers chapters highlighting the use of molecular dynamics and other related methods, application of QM and QM/MM methods in computational drug design, and techniques for navigating and visualizing the chemical space, as well as leveraging big data to drive drug discovery efforts. The book is thoughtfully organized into eight thematic sections, each focusing on a specific computational method or technology applied to drug discovery. Authored by renowned experts from academia, pharmaceutical industry, and major drug discovery software providers, it offers an overview of the latest advances in computational drug discovery. Key topics covered in the book include: Application of molecular dynamics simulations and related approaches in drug discovery The application of QM, hybrid approaches such as QM/MM, and fragment molecular orbital framework for understanding protein-ligand interactions Adoption of artificial intelligence in pre-clinical drug discovery, encompassing protein structure prediction, generative modeling for de novo design, and virtual screening. Techniques for navigating and visualizing the chemical space, along with harnessing big data to drive drug discovery efforts. Methods for performing ultra-large-scale virtual screening for hit identification. Computational strategies for designing new therapeutic models, including PROTACs and molecular glues. In silico ADMET approaches for predicting a variety of pharmacokinetic and physicochemical endpoints. The role of computing technologies like quantum computing and cloud computing in accelerating drug discovery This book will provide readers an overview of the latest advancements in Computational Drug Discovery and serve as a valuable resource for professionals engaged in drug discovery.Table of ContentsVolume 1 Preface xv Acknowledgments xix About the Editors xxi Part I Molecular Dynamics and Related Methods in Drug Discovery 1 1 Binding Free Energy Calculations in Drug Discovery 3Anitade Ruiter and Chris Oostenbrink 2 Gaussian Accelerated Molecular Dynamics in Drug Discovery 21Hung N. Do, Jinan Wang, Keya Joshi, Kushal Koirala, and Yinglong Miao 3 MD Simulations for Drug-Target(Un)binding Kinetics 45Steffen Wolf 4 Solvation Thermodynamics and its Applications in Drug Discovery 65Kuzhanthaivelan Saravanan and Ramesh K. Sistla 5 Site-Identification by Ligand Competitive Saturation as a Paradigm of Co-solvent MD Methods 83Asuka A. Orr and Alexander D. MacKerell Jr. Part II Quantum Mechanics Application for Drug Discovery 119 6 QM/MM for Structure-Based Drug Design: Techniques and Applications 121Marc W. van der Kamp and Jaida Begum 7 Recent Advances in Practical Quantum Mechanics and Mixed-QM/MM-Driven X-Ray Crystallography and Cryogenic Electron Microscopy (Cryo-EM) and Their Impact on Structure-Based Drug Discovery 157Oleg Borbulevych and Lance M. Westerhoff 8 Quantum-Chemical Analyses of Interactions for Biochemical Applications 183Dmitri G. Fedorov Part III Artificial Intelligence in Pre-clinical Drug Discovery 211 9 The Role of Computer-Aided Drug Design in Drug Discovery 213Stormvander Voort, Andreas Bender, and Bart A. Westerman 10 AI-Based Protein Structure Predictions and Their Implications in Drug Discovery 227Tahsin F. Kellici, Dimitar Hristozov, and Inaki Morao 11 Deep Learning for the Structure-Based Binding Free Energy Prediction of Small Molecule Ligands 255Venkatesh Mysore, Nilkanth Patel, and Adegoke Ojewole 12 Using Artificial Intelligence for de novo Drug Design and Retrosynthesis 275Rohit Arora, Nicolas Brosse, Clarisse Descamps, Nicolas Devaux, Nicolas Do Huu, Philippe Gendreau, Yann Gaston-Mathé, Maud Parrot, Quentin Perron, and Hamza Tajmouati 13 Reliability and Applicability Assessment for Machine Learning Models 299Fabio Urbina and Sean Ekins Volume 2 Preface xv Acknowledgments xix About the Editors xxi Part IV Chemical Space and Knowledge-Based Drug Discovery 315 14 Enumerable Libraries and Accessible Chemical Space in Drug Discovery 317Tim Knehans, Nicholas A. Boyles, and Pieter H. Bos 15 Navigating Chemical Space 337Akos Tarcsay, András Volford, Jonathan Buttrick, Jan-Constantin Christopherson, Máte Erdos, and Zoltán B. Szabó 16 Visualization, Exploration, and Screening of Chemical Space in Drug Discovery 365José J. Naveja, Fernanda I. Saldívar-González, Diana L. Prado-Romero, Angel J.Ruiz-Moreno, Marco Velasco-Velázquez, Ramón Alain Miranda-Quintana, and José L. Medina-Franco 17 SAR Knowledge Bases for Driving Drug Discovery 395Nishanth Kandepedu, Anil Kumar Manchala, and Norman Azoulay 18 Cambridge Structural Database (CSD)–Drug Discovery Through Data Mining & Knowledge-Based Tools 419Francesca Stanzione, Rupesh Chikhale, and Laura Friggeri Part V Structure-Based Virtual Screening Using Docking 441 19 Structure-Based Ultra-Large Virtual Screenings 443Christoph Gorgulla 20 Community Benchmarking Exercises for Docking and Scoring 471Bharti Devi, Anurag TK Baidya, and Rajnish Kumar PartVI In Silico ADMET Modeling 495 21 Advances in the Application of In Silico ADMET Models–An Industry Perspective 497Wenyi Wang, Fjodor Melnikov, Joe Napoli, and Prashant Desai Part VII Computational Approaches for New Therapeutic Modalities 537 22 Modeling the Structures of Ternary Complexes Mediated by Molecular Glues 539Michael L. Drummond 23 Free Energy Calculations in Covalent Drug Design 561Levente M. Mihalovits, György G. Ferenczy, and György M. Keseru Part VIII Computing Technologies Driving Drug Discovery 579 24 Orion A Cloud-Native Molecular Design Platform 581Jesper Sorensen, Caitlin C. Bannan, Gaetano Calabrò, Varsha Jain, Grigory Ovanesyan, Addison Smith, She Zhang, Christopher I. Bayly, Tom A. Darden, Matthew T. Geballe, David N. LeBard, Mark McGann, Joseph B. Moon, Hari S. Muddana, Andrew Shewmaker, Jharrod LaFon, Robert W. Tolbert, A. Geoffrey Skillman, and Anthony Nicholls 25 Cloud-Native Rendering Platform and GPUs Aid Drug Discovery 617Mark Ross, Michael Drummond, Lance Westerhoff, Xavier Barbeu, Essam Metwally, Sasha Banks-Louie, Kevin Jorissen, Anup Ojah, and Ruzhu Chen 26 The Quantum Computing Paradigm 627Thomas Ehmer, Gopal Karemore, and Hans Melo Index 679

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Book SynopsisThe pharmaceutical industry is on the cusp of a new age, with the need for personalized therapy, more complex production processes, smaller batch sizes and rising manufacturing costs. It is necessary to continuously adapt to the rapidly changing environment using novel technology and improved operational efficiency and flexibility. To achieve this, intelligent manufacturing seems to be a definite answer. Pharma 4.0 is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing. This book provides a deep insight into key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. Throughout the book we discuss technologies, application and challenges for applying digital technology in pharmaceutical industry, including: • Focus on an overview of Industry 4.0 and its application in the pharmaceutical field• Most recent advances in the pharmaceutical industry• Understanding the concepts of emerging technology trends for drug discovery.Table of Contents1. Digitalization in the Pharmaceutical Industry: Prioritization Throughout Digital Transformation 2. Applications of Industry 4.0 to the Pharmaceutical Sector 3. Blockchain in Pharmaceutical Industry: Opportunities and Challenges 4.Patient Monitoring using Blockchain 5. Potential of AI in Advancement of the Pharmaceutical Industry 6. Use of Artificial Intelligence and Robotics: Making the Drug Development Process Easier 7. Pharmaceutical Packaging: New Impulse Through Artificial Intelligence 8. Digital Assistant in Healthcare Systems: Application and Challenges 9. Deep Learning Techniques and Drug Release 10. Tissue Response Study Using Deep Learning Techniques 11. Issues and Challenges in Bioinformatics Tools for Clinical Trials 12. Advancement in Artificial Intelligence: Insights and Future Vision for Pharmacy Profession

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Book SynopsisIn order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Laboratory Policies and Processes: Using Templates, Project Management, and Six Sigma provides templates for the various policies, procedures, and forms that should be contained in the quality assurance, operational, and technical manuals of a laboratory seeking accreditation.Templates for the entire project life cycleThe book begins with a general introduction and overview of quality assurance and then moves on to cover implementation strategies. It contains best practices and templates for the project management of the design and implementation of the laboratory operational and teTrade Review...The authors do deserve applause for preventing repetitions, which are the norm, rather than exceptions, in books of this kind ... it is an important book which describes how quality has to be managed in any laboratory... —Puneet Setia and Avneesh Gupta, in Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology, Volume 11, Number 2, July - December 2010Table of ContentsINTRODUCTION. POLICY TEMPLATES. Quality Assurance Program Overview. Audits, Inspections and Reviews. Document Control. Equipment and Chemicals. Personnel. Evidence. Laboratory Information Management Systems. Issue Management. Forms. CRITERIA FILES. BIBLIOGRAPHY.

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Book Synopsis

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Book Synopsis

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Book SynopsisThe nutritional and medicinal value of metals, such as zinc, calcium, and iron, has been known in traditional medicine for a long time. Other metals, such as silver and gold, may also have therapeutic and health benefits. Ancient medicines have long incorporated their use in the treatment of diseases, and they have also more recently been explored for treatment in allopathic medicine, birthing the concept of metallonutraceuticals. The challenge of using metals in the human body is to find forms that are safe and effective.Handbook of Metallonutraceuticals presents basic concepts related to the nutritional and therapeutic use of metals, product development strategies, and some ideas ready to be applied for condition-specific metallonutraceuticals. The book begins with an overview of the nutraceuticals field and the need for metallonutraceuticals. It considers the roles of various metals in metabolism, reviews the ethnopharmacology and ethnomedicine of metals, and coverTable of ContentsConcept, Definition, and Need for Metallonutraceuticals. Roles of Metals in Metabolism. Ethnopharmacology and Ethnomedicine of Metals. Characterization of Metallonutraceuticals. Characterization Bioavailability and Drug Interactions of Metallonutraceuticals. Therapeutic Applications of Nanometals. Metallonanotherapeutics for Neurodegenerative Diseases. Nanometals and Complexes in Cancer Diagnosis and Therapy. Application of Metals in Traditional Chinese Medicine. Metalloenzymes: Relevance in Biological Systems and Potential Applications. Application of Nanosilver in Nutraceuticals. Regulatory Pathways and Intellectual Property Rights for Metallonutraceuticals. Gold Nanoparticles: A Promising Nanometallic Drug Delivery System with Many Therapeutic Applications. Index.

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