Pharmaceutical chemistry and technology Books

Book SynopsisThis book reviews the principles of design and examples of successful implementation of proteinkinase inhibitors (PKI), and offers a comprehensive and authoritative overview of the history and latest developments in the field. Chapters written by experts from industry and academia cover the function, structure and topology of Proteinkinases, molecular modelling, disclose how to achieve high level of selectivity for kinase inhibitors, and exploit kinase inhibitors for cancer treatment. Particular attention is given to Inhibitors of c-Jun N-terminal kinase 3, and to covalent Janus Kinase 3 Inhibitors. A case study on Receptor Tyrosine Kinases EGFR, VEGFR, PDGFR is also presented in this book.Given its breath, this book will appeal to medicinal chemists, students, researchers and professionals alike.Table of ContentsProteinKinase-Inhibitors: A Story of Success.- Function, Structure and Topology of Proteinkinases.- Molecular Modelling.- Case study on Receptor Tyrosine Kinases EGFR, VEGFR, PDGFR.- Achieving high level of selectivity for kinase inhibitors.- Inhibitors of c-Jun N-terminal kinase 3.- Exploiting kinase inhibitors for cancer treatment - An Overview of Clinical Results and Outlook.- Covalent Janus Kinase 3 Inhibitors.

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Book SynopsisThis book reviews the principles of design and examples of successful implementation of proteinkinase inhibitors (PKI), and offers a comprehensive and authoritative overview of the history and latest developments in the field. Chapters written by experts from industry and academia cover the function, structure and topology of Proteinkinases, molecular modelling, disclose how to achieve high level of selectivity for kinase inhibitors, and exploit kinase inhibitors for cancer treatment. Particular attention is given to Inhibitors of c-Jun N-terminal kinase 3, and to covalent Janus Kinase 3 Inhibitors. A case study on Receptor Tyrosine Kinases EGFR, VEGFR, PDGFR is also presented in this book.Given its breath, this book will appeal to medicinal chemists, students, researchers and professionals alike.Table of ContentsProteinKinase-Inhibitors: A Story of Success.- Function, Structure and Topology of Proteinkinases.- Molecular Modelling.- Case study on Receptor Tyrosine Kinases EGFR, VEGFR, PDGFR.- Achieving high level of selectivity for kinase inhibitors.- Inhibitors of c-Jun N-terminal kinase 3.- Exploiting kinase inhibitors for cancer treatment - An Overview of Clinical Results and Outlook.- Covalent Janus Kinase 3 Inhibitors.

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Book SynopsisProduct-driven process design – from molecule to enterprise provides process engineers and process engineering students with access to a modern and stimulating methodology to process and product design. Throughout the book the links between product design and process design become evident while the reader is guided step-by-step through the different stages of the intertwining product and process design activities. Both molecular and enterprise-wide considerations in design are introduced and addressed in detail. Several examples and case studies in emerging areas such as bio- and food-systems, pharmaceuticals and energy are discussed and presented. This book is an excellent guide and companion for undergraduate, graduate students as well as professional practitioners.

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Book SynopsisThis book discusses the effects of prolonged hypoventilation, or a pulmonary condition on hypoxia, and hypercapnia, its effect on the formation of some joint diseases, and the types of natural medicine used in the treatment of each joint disease. You will also find methods used to calculate thermodynamic parameters. You can also learn optimized structures for these chemical compounds. The book includes a listing of the thermodynamic table for literature values for standard enthalpy of formation, and C-H and O-H Bond dissociation energizes energies for some chemical compounds; simple multi-fluorinated organic alcohols.

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Book SynopsisDrug misuse is a major challenge for health professionals in the 21st century, and community pharmacy holds a key place in the management of prescribed medication, the provision of health education and promotion messages to drug users. Two decades ago there would have been no need for a book to describe such the role of community pharmacy; however, since more people are injecting drugs now and HIV is on the rise, community pharmacists have found their services in higher demand. The quality practice of tomorrow hinges on trained and competent practitioners working in a variety of community pharmacy settings. Drug Misuse and Community Pharmacy explains the historical, research and practical aspects. Experts use a practical and evidence-based approach to educate students of pharmacy, pre-registration pharmacists, community pharmacists working with drug users and anyone involved in developing and managing primary healthcare for drug misusers.Table of ContentsPart 1: Background. Opiate Addiction and the British System: Looking Back on the Twentieth Century and Trying to see its Shape in the Future. Drug Misuse and the Community Pharmacist: a Historical Overview. Part 2: Surveying the Situation. Reviewing the Situation - Pharmacists and Drug Misuse Services in England and Wales. Drug Misuse and Community Pharmacy in Scotland. Drug Misuse in Northern Ireland: the Role of the Community Pharmacist. Drug Users and Pharmacists: the Client Perspective. Part 3: Working with Drug Users. The History and Operation of Pharmacy Needle Exchanges. New Approaches to Dispensing Controlled Drugs: Supervised Consumption. Providing Health Care for Drug Users. Misuse Over-the-Counter Products. Part 4: Practical Matters - Training, Support and Shared Care. Legal and Ethical Considerations for Community Pharmacists. Training and Support for Pharmacists. Professional Conflicts for the Front-Line Community Pharmacist. Shared Care at the Primary and Secondary Interface: The Role of GPs and Specialist Drug Services. Part 5: The Way Forward. The Way Forward - Greater Specialism or More Generalism?

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Book SynopsisIbuprofen is widely used throughout the world for a variety of conditions. This reference work provides a comprehensive and critical review of the basic science and clinical aspects of the drug. The book begins with the history and development of the drug and its current patterns of use world- wide before moving on to examine its basic pharmaceutical attributes and medicinal chemistry. The properties of various formulations are described (oral prescription and OTC, topical and others) are described. The pharmacokinetics of ibuprofen in animals and humans is discussed - highlighting the factors affecting absorption, distribution, metabolism and elimination. The clinical pharmacology and toxicology and the drug's mechanisms of action in different disease states and conditions are covered. The therapeutic uses in various acute and inflammatory conditions is detailed. Also considered are the safety versus efficacy issues and the pharmacoepidemiological data.Table of Contents1. History and Development of Ibuprofen K.D. Rainsford 2. The Medicinal Chemistry of Ibuprofen K.J. Nichol 3. The Pharmaceutics of Ibuprofen F. Higton 4. The Pharmacokinetcs of Ibuprofen in Humans and Animals D.R. Brocks and F. Jamaili 5. Pharmacology and Toxicology of Ibuprofen K.D. Rainsford 6. Therapeutics of Ibuprofen in Rheumatic and Other Chronic and Painful Diseases W.F. Kean, W.W. Buchanan and K.D. Rainsford 7. Safety and Efficacy of Non-Prescription (OTC) Ibuprofen K.D. Rainsford 8. Use of Ibuprofen in Dentistry R.A. Dionne and S.A. Cooper 9. Gastrointestinal Adverse Drug Reactions Attributed to Ibuprofen D.A. Henry, A. Drew and S. Beuzeville 10. Renal Effects of Ibuprofen M.D. Murray and D.C. Brater 11. Adverse Drug Reactions Attributed to Ibuprofen: Effects Other Than Gastrointestinal L.J. Miwa and J.K. Jones 12. Human Toxicity of Ibuprofen G.N. Volans and R. Fitzpatrick Nichol, Boots Pharmaceuticals, UK, F. Higton, Boots Healthcare International, D.R. Brock, Western University of Health Sciences, USA, F. Jamaili, University of Alberta, USA, W.F. Kean, McMaster University, Canada, W.W. Buchanan, Sir William Osler Health Institute, Canada, R.A. Dionne, National Istitute of Health, USA, S.A. Cooper, Whitehall-Robins Health Care, USA, D.A. Henry, Newcastle Mater Hospital, Australia, A. Drew, Newcastle Mater Hospital, Australia, S. Beuzeville, Newcastle Mater Hospital, Australia, M.D. Murray, Regenstrief Health Centre, USA, D.C. Brater, Indiana university School of Medicine, USA, L.J. Miwa, The Degge Group, USA, J.K. Jones, The Degge Group, USA, G.N. Volans, Guys and St. Thomas' Hospital Trust, UK, R. Fitzpatrick, Guys and St. Thomas' Hospital Trust, UK.

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Book SynopsisThe book provides an exhaustive, authoritative and updated review on the interindividual variability in drug metabolism in humans. Four chapters address the general background: genetic factors causing variability, interethnic variability, environmental factors and developing and ageing as sources of variability. Six chapters address variability of drug metabolism in vivo: variability of psychotropic drugs, antiepileptic drugs, the dopamine precursor levodopa, cardiovascular active drugs and anti HIV drugs. Seven chapters address the interindividual variability of the main drug metabolizing enzymes: CYP-450s, acetyltransferases, glucuronosyl transferase, methyl transferases, sulfotransferases and glutathione transferases in human liver and extrahepatic tissues. A separate chapter discusses the prediction of drug interaction.Comprehensive in coverage, and with contributions from the leading international experts, this book is essential reading for researchers from both academiTable of ContentsGenetic Factors That Cause Variability in Human Drug Metabolism. Interethnic Differences in Drug Disposition and Effects. Developing and Ageing as Sources of Variability in Drug Metabolism. Genetic and Environmental Factors Causing Variability in Psychotropic Drug Response. Interindividual Variability in the Metabolism of Cardiovascular Drugs. Interindividual Variability in the Metabolism of Antiepileptic Drugs and its Clinical Implications. Variability in the Metabolism of Levodopa and its Clinical Implications. Interindividual Variability in the Disposition of Anti-HIV Drugs. Predictive Modeling of in vivo Drug Interaction From in vitro Data: From Theory to a Computer-based Workbench and Experimental Validation. Interindividual Variation of P450 Enzymes in vitro and it's Causes. Interindividual Variability of Arylamine N-acetyltransferases. Interindividual Variation of UDP-glucuronosyl Transferases and Drug Glucuronidation. Interindividual Variability of Methyltransferases. Interindividual Variability of Sulpho Transferases. Interindividual Variability of Glutathione Transferase Expression

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Book SynopsisReviewing over a century of aspirin research and use, Aspirin and Related Drugs provides a comprehensive source of information on the history, chemistry, absorption in the body, therapeutic effects, toxicology, elimination, and future uses of aspirin.Highlighting the historical evolution of the salicylates and the commercial development of aspirin, the book reviews the pharmacokinetics of the salicylates, ibuprofen, and paracetamol as a basis for understanding the biodisposition of these analgesic drugs. Leading specialists discuss the therapeutic role of aspirin in the prevention and treatment of thrombo-embolic diseases, its place along with non-acetylated salicylates in the treatment of rheumatic diseases and plain, and the potential applications for aspirin and related drugs as prophylactics for colon cancer, Alzheimer's disease, and vascular dementia. They also present comparisons with other drugs used to treat pain and inflammation.With extensive data and literTable of ContentsHistory and Development of the Salicylates. The Industrial History of Analgesics: The Evolution of Analgesics and Antipyretics. Occurrence, Properties and Synthetic Developments of the Salicylates. Pharmacokinetics and Metabolism of the Salicylates. Metabolism and Pharmacokinetics of Ibuprofen. Pharmacokinetics and Metabolism of Paracetamol (Acetaminophen). Pharmacology and Biochemistry of Salicylates and Related Drugs. Side-effects and Toxicology of the Salicylates. Reye's Syndrome and Aspirin. Salicylates in the Treatment of Acute Pain. Acetysalicylic Acid for the Prevention and Treatment of Thromboembolic Diseases. Use of Salicylates in Rheumatic and Related Conditions. Aspirin and NSAIDs in the Prevention of Cancer, Alzheimer's Disease and other Novel Therapeutic Actions.

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

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Book SynopsisUpdating researchers on phenomenal progress in the field of molecular medicine the Encyclopedia of Medical Genomics and Proteomics offers trail-blazing studies and authoritative contributions from more than 400 specialists. An important and timely contribution to the biomedical community, the encyclopedia compiles recommendations and research and features coverage of key methods and technologies related to a range of areas. Topics include:Molecular diagnosticsGenomics, microbiology, genetics, and pharmacogeneticsManagement of infectious, neoplastic, and genetic diseasesTreatment of chronic, hereditary, and congenital disordersMedical applications of nucleic acid and protein technologyCell typingDisease susceptibility Predictive genetic and pharmacogenetic testing and tissue typing for transplantationDNA sequencing, point-of-care testing, and quality managementOncology and cancer screeningPathology and forensic issuesDiagnostic microbiology and molecular pathologyEthical issues related to genetics Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including:Citation tracking and alertsActive reference linkingSaved searches and marked listsHTML and PDF format optionsContact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages.US: (Tel) 1.888.318.2367; (E-mail) e-reference@taylorandfrancis.comInternational: (Tel) +44 (0) 20 7017 6062; (E-mail) online.sales@tandf.co.uk

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Book SynopsisKnowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered.Breaking the project life-cycle into four phases, the text takes you through each phase from thTable of ContentsIntroduction to Facility Project Management Project Formation Defining the Project Team Facility Programming Project Control Current Good Manufacturing Practice (cGMP): Project Impacts Mechanical Systems GMP Compliance in Architectural Design and Construction Commissioning Quality Management to Meet Regulatory Requirements Establishment Licensing Containment Basics Multi-product Facilities for Biologics Contract Formulation and Philosophy Future Trends

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Book SynopsisCompletely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology. Packed with information useful to both the novice and the expert, it includes line-drawing illustrations, filtration setups, and plots of math functions illustrating fluid flows through filter media built from a random packing of solids. The book provides in-depth discussions of general filtration, specific membranes used in filtration, integrity testing, earlier filtration steps, and cross-flow filtration. It also includes a useful, updated appendix of worldwide contacts and many sources for equipment, supplies, and information.Table of ContentsCompletely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology. Packed with information useful to both the novice and the expert, it includes line-drawing illustrations, filtration setups, and plots of math functions illustrating fluid flows through filter media built from a random packing of solids. The book provides in-depth discussions of general filtration, specific membranes used in filtration, integrity testing, earlier filtration steps, and cross-flow filtration. It also includes a useful, updated appendix of worldwide contacts and many sources for equipment, supplies, and information.

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Book SynopsisThe assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physicaTable of ContentsIntroduction - Bioequivalence Issues. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Pharmaceutical Alternatives: Considerations for Generic Substitution. Pharmacodynamic Measurements for Determination of Bioequivalence. Bioequivalence Using Clinical Endpoint Studies. Evaluation of Bioequivalence of Highly-Variable Drug Products. Statistical Considerations: Alternate Designs And Approaches For Bioequivalence Assessments. Population Pharmacokinetic Approaches for Assessing Bioequivalence. Role of Metabolites in Bioequivalence Assessment. Implications of Chirality for the Assessment of Bioequivalence. Effect of Food on Bioavailability and the Assessment of Bioequivalence. Bioequivalence Assessment of Endogenous Drug Substances : Pharmacokinetics and Statistical Evaluation.

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Book SynopsisEssentials of Pharmaceutical Chemistry is an introduction to pharmaceutical chemistry for undergraduate pharmacy, chemistry and medicinal chemistry students. It covers all of the core material necessary to provide an understanding of the basic chemistry of drug molecules.Trade Review "...Donald Cairns is a well-known educator, mentor, and researcher...this is an excellent resource for pharmacy students taking pharmaceutical chemistry and for individuals who intend to pursue a career in the pharmaceutical industry...Readers will find this as a useful reference." Rahmat M Talukder, Ph.D.,Doody's Notes, May 2012. -- Rahmat M Talukder * Doody's Notes *"This is a great book detailing the basic chemistry of drugs...Throughout the book there are problems that can be worked, and it includes the answers at the end of the book. It is very easy-to-read and has very good graphics to support the discussions. In addition to being a good text, it is a good refresher for those that would like to review this topic."Compounding Today, 27 Jan 2012. * Compounding Today *Table of Contents1. Chemistry of Acids and Bases; 2. Partition Coefficient and Biopharmacy; 3. Physicochemical Properties of Drugs; 4. Stereochemistry; 5. Drug Metabolism; 6. Volumetric Analysis of Drugs; 7. Analytical Spectroscopy; 8. Chromatographic Methods of Analysis; 9. Stability of Drugs and Medicines; 10. Kinetics of Drug Stability; 11. Licensing of Drugs and the British Pharmacopoeia; 12. Medicinal Chemistry - the Science of Rational Drug Design; 13. Answers to Problems

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Book SynopsisAcute toxicology testing constitutes the first line of defense against potentially dangerous chemicals. This book provides a detailed presentation of protocols for each of the common designs, reviews their development and objectives, discusses the types of data they generate, and examines the current status of alternative test designs and models. For each test, applicable U.S. and international guidelines are also presented, and the formulation and selection of vehicles, dosages, and test animals are addressed.

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Book SynopsisA Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.Unique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and Trade Review'"A Practical Guide to Managing Clinical Trials" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing makes the book a quick read.' – Norman M. Goldfarb for Journal of Clinical Research Best Practices, Vol. 13, No. 12, December 2017.'"A Practical Guide to Managing Clinical Trials" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing makes the book a quick read.' – Norman M. Goldfarb for Journal of Clinical Research Best Practices, Vol. 13, No. 12, December 2017.Table of ContentsChapter 1: Rules, Roles and ResponsibilitiesChapter 2: Products, Protocols, and Pre-trial PreparationChapter 3: Sponsor, Site and Study Start-upChapter 4: Enticement, Enrollment, and Engagement: The Informed Consent ProcessChapter 5: From Enrollment to Final VisitChapter 6: Collaborating for Compliance and Quality Data – Monitoring and AuditsChapter 7: Building BudgetsChapter 8: Contracts, Clauses and Closing the DealChapter 9: US Clinical Trials – Additional TopicsChapter 10: Clinical Research and India

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Book SynopsisCompletely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments. New chapters cover evolving areas regarding biopharmaceuticals, including oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical approval processTable of ContentsMolecular Biotechnology. Biophysical and Biochemical Analysis of Recombinant Protein Structure and Analysis of Proteins. Production and Downstream Processing of Biotech Products. Formulation of Biotech Products, Including Biopharmaceutical Considerations. Pharmacokinetics and Pharmacodynamics of Peptide and Protein Drugs. Immunogenicity. Genomics, Proteomics and Additional Biotechnology-related Techniques. Gene Therapy. Oligonucleotides and siRNA. Hematopoetic Growth Factors. Interferons and Interleukins. Insulins. Growth Hormones. Recombinant Thrombolytics and Coagulation Factors. General Considerations of Monoclonal Antibodies. Monoclonal Antibodies in Oncology. Monoclonal Antibodies in Transplantation. Monoclonal Antibodies in Anti-inflammatory Therapy. Recombinant Human Deoxyribonuclease. Follicle-stimulating Hormone. Vaccines. Dispensing Biotechnology Products. Economic Considerations in Medical Biotechnology. Regulatory Issues and Drug Product Approval for Biopharmaceuticals

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Book SynopsisNovel drug delivery technologies strive to bypass challenging biological layers to elicit desired pharmacological activity. The skin, one of our key defensive barriers, allows certain topically applied substances and toxins to pass. The dermatokinetics of a drug determines the efficacy of treatment of skin disorders.Presenting the first comprehensive reference on this important area of research, Dermatokinetics of Therapeutic Agents includes a general overview of the theoretical as well as practical aspects of dermatokinetics and addresses the impact of a drug delivery system on the dermatokinetics of drugs. Chapters and illustrations cover introductory aspects and the significance, methods, and models used in dermatokinetic studies of therapeutic agents.Topics include: Theoretical Models for Dermatokinetics of Therapeutic Agents Drug Delivery Approaches to Modulate Dermatokinetics of DrugsTable of ContentsIntroduction to Dermatokinetics. Theoretical Models for Dermatokinetics of Therapeutic Agents. Drug Delivery Approaches to Modulate Dermatokinetics of Drugs. Conventional Methods of Cutaneous Drug Sampling. Cutaneous Microdialysis. Sampling Substrates by Skin Permeablization. Spectroscopic Techniques in Dermatokinetics Studies. Dermatokinetics of Gene Therapeutics. Regulatory Perspective of Dermatokinetic Studies.

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Book SynopsisMaintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over Trade Review"The two authors are well-respected statisticians with numerous publications in BE and broad pharmaceutical industry experience. … The book is written in plain language and statistics is presented with minimum mathematical proof, which makes it a great introduction and reference for statisticians and clinical pharmacologists. With case studies and associated SAS and R codes included in the book and website, both statisticians and clinical pharmacologists will find this book helpful in understanding the context to use a method and implementing the ready-to-use codes. Particularly, each chapter begins with an interesting real-life story of the authors working as statisticians in the pharmaceutical industry, which makes the reading delightful. …In summary, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition, provides an update on regulatory recommendations, statistical methods, and applications in clinical pharmacology and BE studies to support drug product development. With its inclusion of SAS and R codes, this book will be a valuable reference for pharmaceutical scientists, statisticians, and regulators working in these areas."—Wangjie Sun and Wenlei Jiang, US Food and Drug Administration, in Journal of the American Statistical Association, January 2018"This book is a second edition of the authors’ take on the concepts and methods in the analysis and design of bioequivalence studies, supported by references to regulation authorities’ guidelines ... The authors are working in the pharmaceutical industry and therefore bring a view from the inside compared to the other reference work in the field by academics … Throughout the book, different examples with data and codes are provided both showing and not showing bioequivalence to facilitate the learning process. … To conclude, this book covers efficiently the statistical methods of bioequivalence testing and their many applications in clinical pharmacology. Furthermore, the dense reference list provides a helpful guide for the reader to go in deeper details on topics of interest."—Julie Bertrand, Faculté de Médecine Bichat, IAME, in Journal of Biopharmaceutical Statistics, May 2017"The first edition of Bioequivalence and Statistics in Clinical Pharmacology was a classic text book for researchers and statisticians in the field of clinical pharmacology and pharmaceutical industry. This new second edition is a timely update with the inclusion of new areas such as adaptive bioequivalence trials, scaled average bioequivalence testing, and vaccine trials. This is one of few books in the literature with the focus on statistical issues in clinical pharmacology and bioequivalence. The topics it covers are critical for understanding the pharmacology of an investigational drug, and are becoming increasingly important in the era of precision medicine. The book is just as well structured as the first edition, in an accessible, thorough, and clear manner. Case studies and associated SAS code included in the book are extremely helpful. In summary, the book is a most welcome addition to the collection of pharmaceutic statisticians and researchers in clinical pharmacology." —Liang Fang, Director of Biostatistics, Gilead Sciences Inc."Bioequivalence and Statistics in Clinical Pharmacology, Second Edition, provides readers with a statistical background of bioequivalence and presents several special topics in clinical pharmacology. This second edition contains updated and extended discussions of these topics and includes new chapters on adaptive bioequivalence studies, scaled average bioequivalence, and vaccine trials. The book’s presentation is comprehensive and clear, and is complimented by numerous illustrations, examples, and computer programs with data analyses. Scientists and practitioners working in industry, regulatory authorities, and academia will find this book useful, interesting, and enjoyable due to the delightful and instructive stories featured in the introductions of each chapter, the various important and relevant topics covered by these chapters, and the informative and practical technical appendices."—Laszlo Endrenyi, Professor Emeritus, University of TorontoPraise for the First Edition:"… the book provides a good introduction to common uses of statistics in early phases of the drug development process by using a good mix of technical detail, intuitive understanding and factual knowledge. … personal accounts together with the numerous real data examples which are accompanied by SAS code for analysis and the opportunity to download the data to gain first-hand experience are the best features of the book. … the authors did a fine job in providing an introduction to statistics in the early stages of the drug development process. The availability of real example data allows the reader to engage himself easily in the topic and the long experience of the authors ensures that many different aspects of pharmacological studies are discussed."—Thomas Jaki, Lancaster University, Journal of the Royal Statistical Society, Series A, 2010"I really enjoyed reading this book. Each chapter includes an excellent introduction based on Scott Patterson's experience working as a biometrician. This will especially be of interest to young statisticians starting their career in the pharmaceutical industry. Therefore, I strongly recommend this book to all pharmaceutical statisticians to learn more of the challenging statistical problems being generated in drug development. In addition, the presented material provides a springboard for all scientists from academia who are looking to do research in this area of medical applications."—Dieter Haushcke, Biometrics, September, 2006"The authors formulate bioequivalence exhaustively and clearly. … Given the background of the authors, they constitute a key piece of social information in understanding the context in which clinical pharmacology research develops within the pharmaceutical industry."—Journal of Biopharmaceutical Statistics"The two authors are well-respected statisticians with numerous publications in BE and broad pharmaceutical industry experience. … The book is written in plain language and statistics is presented with minimum mathematical proof, which makes it a great introduction and reference for statisticians and clinical pharmacologists. With case studies and associated SAS and R codes included in the book and website, both statisticians and clinical pharmacologists will find this book helpful in understanding the context to use a method and implementing the ready-to-use codes. Particularly, each chapter begins with an interesting real-life story of the authors working as statisticians in the pharmaceutical industry, which makes the reading delightful. …In summary, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition, provides an update on regulatory recommendations, statistical methods, and applications in clinical pharmacology and BE studies to support drug product development. With its inclusion of SAS and R codes, this book will be a valuable reference for pharmaceutical scientists, statisticians, and regulators working in these areas."—Wangjie Sun and Wenlei Jiang, US Food and Drug Administration, in Journal of the American Statistical Association, January 2018"This book is a second edition of the authors’ take on the concepts and methods in the analysis and design of bioequivalence studies, supported by references to regulation authorities’ guidelines ... The authors are working in the pharmaceutical industry and therefore bring a view from the inside compared to the other reference work in the field by academics … Throughout the book, different examples with data and codes are provided both showing and not showing bioequivalence to facilitate the learning process. … To conclude, this book covers efficiently the statistical methods of bioequivalence testing and their many applications in clinical pharmacology. Furthermore, the dense reference list provides a helpful guide for the reader to go in deeper details on topics of interest."—Julie Bertrand, Faculté de Médecine Bichat, IAME, in Journal of Biopharmaceutical Statistics, May 2017"The first edition of Bioequivalence and Statistics in Clinical Pharmacology was a classic text book for researchers and statisticians in the field of clinical pharmacology and pharmaceutical industry. This new second edition is a timely update with the inclusion of new areas such as adaptive bioequivalence trials, scaled average bioequivalence testing, and vaccine trials. This is one of few books in the literature with the focus on statistical issues in clinical pharmacology and bioequivalence. The topics it covers are critical for understanding the pharmacology of an investigational drug, and are becoming increasingly important in the era of precision medicine. The book is just as well structured as the first edition, in an accessible, thorough, and clear manner. Case studies and associated SAS code included in the book are extremely helpful. In summary, the book is a most welcome addition to the collection of pharmaceutic statisticians and researchers in clinical pharmacology." —Liang Fang, Director of Biostatistics, Gilead Sciences Inc."Bioequivalence and Statistics in Clinical Pharmacology, Second Edition, provides readers with a statistical background of bioequivalence and presents several special topics in clinical pharmacology. This second edition contains updated and extended discussions of these topics and includes new chapters on adaptive bioequivalence studies, scaled average bioequivalence, and vaccine trials. The book’s presentation is comprehensive and clear, and is complimented by numerous illustrations, examples, and computer programs with data analyses. Scientists and practitioners working in industry, regulatory authorities, and academia will find this book useful, interesting, and enjoyable due to the delightful and instructive stories featured in the introductions of each chapter, the various important and relevant topics covered by these chapters, and the informative and practical technical appendices."—Laszlo Endrenyi, Professor Emeritus, University of TorontoPraise for the First Edition:"… the book provides a good introduction to common uses of statistics in early phases of the drug development process by using a good mix of technical detail, intuitive understanding and factual knowledge. … personal accounts together with the numerous real data examples which are accompanied by SAS code for analysis and the opportunity to download the data to gain first-hand experience are the best features of the book. … the authors did a fine job in providing an introduction to statistics in the early stages of the drug development process. The availability of real example data allows the reader to engage himself easily in the topic and the long experience of the authors ensures that many different aspects of pharmacological studies are discussed."—Thomas Jaki, Lancaster University, Journal of the Royal Statistical Society, Series A, 2010"I really enjoyed reading this book. Each chapter includes an excellent introduction based on Scott Patterson's experience working as a biometrician. This will especially be of interest to young statisticians starting their career in the pharmaceutical industry. Therefore, I strongly recommend this book to all pharmaceutical statisticians to learn more of the challenging statistical problems being generated in drug development. In addition, the presented material provides a springboard for all scientists from academia who are looking to do research in this area of medical applications."—Dieter Haushcke, Biometrics, September, 2006"The authors formulate bioequivalence exhaustively and clearly. … Given the background of the authors, they constitute a key piece of social information in understanding the context in which clinical pharmacology research develops within the pharmaceutical industry."—Journal of Biopharmaceutical StatisticsTable of ContentsBioequivalence & Biopharmaceutical DevelopmentDrug Development and Clinical PharmacologyAims of This BookBiopharmaceutical DevelopmentClinical PharmacologyStatistics in Clinical PharmacologyStructure of the BookHistory and Regulation of BioequivalenceWhen and How BE Studies Are PerformedWhy Are BE Studies Performed?Deciding When Formulations Are BioequivalentPotential Issues with TOST BioequivalentCurrent International RegulationSome Practical NotesTesting for Average BioequivalenceBackgroundLinear Model for 2 x 2 DataApplying the TOST ProcedureCarry-over, Sequence, and Interaction EffectsChecking Assumptions Made about the Linear ModelPower and Sample Size for ABE in the 2 x 2 DesignExample Where Test and Reference Are Not ABENonparametric AnalysisBE Studies with More Than Two PeriodsBackgroundThree-period DesignsWithin-subject VariabilityRobust Analyses for Three Period DesignsFour-period DesignsDesignes with More Than Two TreatmentsAdjusting for Multiple TestingNonparametric Analyses of TmaxTechnical appendix: EfficiencyTables of DataSpecial Topics in BioequivalenceDealing with Special BE ChallengesRestricted Maximum Likelihood ModellingFailing BE and the DER AssessmentSimulationData-based SimulationCarry-overOptimal DesignsDetermining Trial SizeWhat Outliers Are and How to Handle Their DataBayesian BE AssessmentAdaptive Bioequivalence TrialsBackgroundTwo-stage design for testing for ABETOST using the standard combination testExample of using the standard combination testThe maximum combination testExample of using the maximum combination testConditional errors and conditional powerAlgorithm for sample size re-estimationOperating characteristicsConclusionsTechniccal Appendix: R codeScaled Average Bioequivalence TestingBackgroundScaled Average Bioequivalence in EuropeScaled Average Bioequivalence in USADiscussion and CautionsClinical PharmacologyClinical Pharmacology Safety StudiesBackgroundFirst-time-in-humansSub-chronic Dosing StudiesFood-Effect Assessment and DDIsDose-ProportionalityTechnical AppendixQTcBackgroundModelling of QTc DataInterpreting the QTc Modelling FindingsDesign of a Thorough QTc Study in the FutureClinical Pharmacology Efficacy StudiesBackgroundSub-chronic DosingPhase IIa and the Proof of ConceptPopulation PharmacokineticsPopulation and PharmacokineticsAbsolute and Relative BioavailabilityAge and Gender Pharmacokinetic StudiesEthnicityLiver DiseaseKidney DiseaseTechnical Appendix Vaccines & Epilogue Vaccine TrialsBrief Introduction to Vaccine Research and DevelopmentPhase I Vaccine StudiesProof of Concept and Phase IILot ConsistencyConcomitant VaccinationCross-over Trials in VaccinesEpilogue BibliographyIndex

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Book SynopsisSince 1945, The Annual Deming Conference on Applied Statistics has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry.Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical triTrade Review"This book of timely, self-contained chapters covers a wide range of current methods and unresolved challenges in clinical trial statistical methods and will prove to be an essential guide for biostatisticians who work in this field."—Dirk F. Moore, Journal of Biopharmaceutical Statistics". . . the contributed chapters in this collection are clearly written, easily digestible, and well-referenced. The book is a useful resource for the clinical trialist interested in obtaining a quick overview of standard practices and current methodological development for a specific biostatistical application, or a worthwhile read for the researcher seeking to familiarize him or herself with a diversity of emerging topics in clinical trials.—Megan T. Smith, University of California, IrvineTable of ContentsEmerging Issues in Clinical Trial Design and Analysis. Adaptive Clinical Trials. Clinical Trials in Oncology. Multiple Comparisons in Clinical Trials. Clinical Trials in the Genomic Era. Index.

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Book SynopsisAs the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements.New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary andTrade Review"This handbook offers a complete description of every aspect of bioequivalence testing … [It] is an essential, one-of-a-kind resource for anyone interested in bioequivalence. There are no other books that compile so many aspects in one place."—Jennifer L. Colon, PharmD, Temple University School of Pharmacy, in Doody’s Review Service Table of ContentsHistorical Perspective on Generic Pharmaceuticals. Physicochemical Basis of Bioequivalence Testing. Drug Delivery Factors. Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling. Bioequivalence Testing Rationale and Principles. Bioequivalence Waivers. Statistical Evaluation of Bioequivalence Data. Regulatory Inspection Process. Fed Bioequivalence Studies. Topical Drugs. Bioequivalence of Nasal Products. Bioequivalence of Complementary and Alternate Medicines. Bioequivalence of Biosimilar Products. Bioequivalence Testing: The US Perspective. Bioequivalence Testing: European Perspective. Bioequivalence Testing: The ROW Perspective. Bioequivalence Testing Protocols. Bioequivalence Documentation. Good Laboratory Practices. Bioanalytical Method Validation. Good Clinical Practice. Computer and Software Validation. Outsourcing and Monitoring of Bioequivalence Studies. Epilogue: Future of Bioequivalence Testing. Appendix A: Glossary of Terms. Appendix B: Dissolution Testing Requirements for US FDA Submission. Bibliography. Index.

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Book SynopsisAdverse Drug Interactions: A Handbook for Prescribers assists clinicians by providing key information on potential adverse effects that can result from prescribing two or more drugs for simultaneous use. Interactions that are likely to give rise to life-threatening conditions, and which must therefore be completely avoided, are clearly highlighted. Less threatening but nonetheless important interactions necessitating practical measures, such as frequent monitoring and advice to patients, are also discussed.Presented in a user-friendly format, the book is organised by drug class and provides a brief summary of the mechanism underlying a particular interaction, alternative drugs lacking the same reactions that may be considered, and instructions for monitoring patients when adverse effects occur. All interactions listed in the previous edition have been reviewed and updated using the latest information available. The clinical reality of tTrade Review“There is much to commend. There are useful preliminary sections on the complexity of drug–drug interactions and the emerging role of electronic decision support systems… I was particularly pleased to see the inclusion of interactions with herbal and common over-the-counter medications, alcohol, ‘classic’ recreational drugs, vitamins and minerals, and key food groups.”—Daniel Marks, University College London Hospital, London, British Journal of Hospital MedicineTable of ContentsDrugs Acting on the Cardiovascular System. Drugs Acting on the Central Nervous System. Anticancer and Immunomodulating Drugs. Anticoagulants. Antidiabetic Drugs. Other Endocrine Drugs. Analgesics. Musculoskeletal Drugs. Anesthetic Drugs: General. Drugs to Treat Infections. Drugs Acting on the Gastrointestinal Tract. Respiratory Drugs. Metabolic Drugs. Obstetrics and Gynecology. Drugs Used to Treat the Urinary System. Drugs of Abuse. Miscellaneous. Over-the-Counter/Online Drugs, Traditional and Herbal Remedies. Appendices.

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Book SynopsisThe recent introduction of nanomedicines in the drug therapy arena is revolutionizing the management of severe diseases. The key advance in the field is the optimization of the biological fate of drug molecules, thus improving the therapeutic effect while keeping to a very minimum the associated toxicity. Volume one of this book series, Nanoplatforms in Drug Delivery, established the basic aspects in the development of drug-loaded nanoplatforms, the so-called nanomedicines or nanodrugs, focusing on representative materials and strategies used in their formulation. Taking advantage of the advanced conceptualizations on nanomedicine engineering that were described in volume one, volume two, Nano-Engineering Strategies and Nanomedicines against Severe Diseases, analyzes in depth special features related to the formulation of nanoplatforms for oral, dental, topical and transdermal, pulmonary and nasal, ocular and otic, vaginal, and brain drug delivery Table of ContentsPreface to the Book Series. Preface to Volume 2. Emerging Technologies of Polymers for Nanomedicine Applications. Nanotechnology for Oral Drug Delivery and Targeting. Nanoparticulate Systems for Dental Drug Delivery. Nanotechnology for Topical and Transdermal Drug Delivery and Targeting. Nanotechnology for Pulmonary and Nasal Drug Delivery. Lipid Nanoplatforms for Pulmonary Drug Delivery. Nanotechnology for Ocular and Otic Drug Delivery and Targeting. Nanotechnology for Vaginal Drug Delivery and Targeting. Potential Nanocarriers for Brain Drug Delivery. Nanomaterials and Cancer Therapy. Nanomedicine in Cardiovascular Disease. Nano(Neuro)Medicinal Interventions for Neurodegenerative Disorders: a Meta-Analysis of Concurrent Challenges and Strategic Solutions. Nanomedicines against Infectious Diseases. Nanomedicines against Chronic Inflammatory Diseases. Nanomedicine Biopharmaceuticals for Metabolic Diseases. Nanotechnology in Gene Knockdown and miRNA Replacement in Vivo. Nanotheranostics.

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Book SynopsisThe premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation. Table of ContentsBACKGROUND. Introduction. ANALYTICAL METHOD. Statistical Methods for Analytical Procedure Development, Validation and Transfer. Parallelism Testing of Bioassay. Validation of Assay Linearity. ROCESS DEVELOPMENT. Residual Host Cell DNA Risk Assessment. Statistical Evaluations of Viral Clearance. Pre-filtration Bio-burden Testing. Process Validation and Verification. MANUFACTURING. Specifications.

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Book SynopsisThe emergence of nanotherapeutics is attributable to the integration of nanotechnology, recombinant DNA technology, and synthetic organic chemistry with medicine for treating critical human diseases in a more efficient and specific molecular approach than therapy with conventionally-designed and formulated drugs. Nanotherapeutics: From Laboratory to Clinic comprehensively discusses the current shortcomings for delivery of classical (small) drugs, macromolecular therapeutics, and recombinant vaccine via the common intravascular and extravascular routes.The book describes the synthetic/chemical engineering methods as well as recombinant, hybridoma, and phage display technologies to fabricate different types of nanoparticulate carriers and drugs. It also reveals the diversified approaches undertaken by harnessing nanotechnology to overcome the multistep extracellular and intracellular barriers and to facilitate the development of novel strategies for therapeutic deTable of ContentsEmergence of nanotherapeutics: Challenges in classical drug transport versus macromolecular drug design. The ultimate destinations for delivery and release of nanotherapeutics. Diversity of bioactive nanoparticles from biological, chemical, and physical perspectives. Fabrication strategies for biofunctional nanoparticles. Interactions and orientation of therapeutic drugs in the vicinity of nanoparticles. Variable interactions of nanoparticles with blood, lymph, and extracellular and intracellular components. Pharmacokinetics and biodistribution of nanoparticles. Specific roles of nanoparticles in various steps of drug transport. Nanotechnology approaches to modulate transport, release, and bioavailability of classical and emerging therapeutics. Nanotechnology in the development of innovative treatment strategies. Nanoparticles for therapeutic delivery in animal models of different cancers. Nanoparticles for therapeutic delivery in animal models of other critical human diseases. Nanomedicine in clinical trials. Approved and commercialized nanomedicine. Current safety issues: Biodegradability, reactivity, and clearance. References.

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Book SynopsisMarine glycobiology is an emerging and exciting area in the field of science and medicine. Glycobiology, the study of the structure and function of carbohydrates and carbohydrate-containing molecules, is fundamental to all biological systems and represents a developing field of science that has made huge advances in the last half-century. This book revolutionizes the concept of marine glycobiology, focusing on the latest principles and applications of marine glycobiology and their relationships.Trade Review"The book describes carbohydrates conjugated with additional molecules – an area that could be called terra incognita, because it has been unexploited until now. An important part of the book constitutes analytical techniques, which are a challenge. Another important aspect is the practical application of those unique compounds: in biomedicine, bio-based technologies. The book contains 6 sections and 38 chapters which thoroughly discuss different aspects of glycoconjugates. The book would be useful for academic research, students, but also for industry, as the inspiration for development of innovative and bioactive products."— Katarzyna Chojnacka, Wroclaw University of Technology, PolandTable of ContentsIntroduction to Marine Glycobiology. Marine Glycoconjugates of Reproduction and Chemical Communications. Marine Glycans. Marine Glycosylation. Marine Glycoproteins. Marine Proteoglycans. Marine Glycolipids. Marine Glycomics. Marine Glycoenzymes. Marine Carbohydrates. Bioinformatics of Glycobiology. Biological Role of Glycoconjugates. Glycoconjugates in Biomedicine and Biotechnology.

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Book SynopsisIndustrial Applications of Marine Biopolymers presents different classes of marine biopolymers and their industrial applications, demonstrating the precious value of ocean resources to society. This timely volume discusses the exceedingly useful polymers derived from these materials that are biodegradable, biocompatible, and at times water soluble. Direct use or chemically modified forms of such biomaterials have many chemical sites, making them suitable for varied types of industrial applications. In addition, this book also addresses current global challenges of conservation, including extended drought conditions and the need for improved agricultural methods, together with new bio-medical developments. It is suitable for anyone who has an interest in the industrial applications of biopolymers.Table of ContentsPart – I Isolation and physicochemical characterization of marine biopolymers. Introduction to marine biopolymers. Isolation of marine biopolymers. Physicochemical characterization of marine biopolymers. Isolation and characterization of chitin and chitosan. Isolation and characterization of alginate from seaweeds. Isolation and characterization of carrageenans and agar / agarose. Influence of physicochemical properties of chitin and chitosan on its potential applications. Structural characteristics of marine biopolymers. Isolation and characterization techniques used for hydroxyapatite. Biosynthesis of marine biopolymers. Electrostatic properties of marine biopolymers. Applications of analytical tools such as NMR, IR and Mass spectrometry to analyse the structural properties of marine biopolymers. Mechanical properties of Marine biopolymers and its derivatives. Use of X-Ray diffraction analysis on Marine biopolymers. Production of marine biopolymers through enzymatics process. Chemical modification of chitin and chitosan for its potential applications. Enzymatic modification of marine biopolymers. Effect of Molecular weight and the degree of deacetylation of chitosan and its determination. Isolation and characterization of hyaluronic acid. Isolation of low-molecular weight biopolymers from marine sources. Physio-chemical characterization of tunicin, laminarin and furcellaran. Isolation and characterization of inorganic biopolymer.Part – II Biological and Biomedical applications of the marine biopolymers Chapter 1: Marine biopolymers for anti-cancer drugs.Chapter 2: Drug Delivery applications of chitin and chitosan.Chapter 3: Gene delivery applications of chitin and chitosan.Chapter 4: Biological activities of Marine biopolymers.Chapter 5: Applications of nano form of biopolymers.Chapter 6: Nanocomposites and nanoparticles of biopolymers in bio-nano-technology.Chapter 7: Antimicrobial activity of marine biopolymers.Chapter 8: Role of Alginate in drug delivery applications.Chapter 9: Application of marine hydroxyapatite scaffolds in bone tissue engineering.Chapter 10: Modified marine polysaccharides and Seaweads in drug delivery applications.Chapter 11: Marine biopolymers as carriers and immunoadjuvants in vaccine delivery.Chapter 12: Antidiabetic activity and anticolestic activity of marine biopolymers.Chapter 13: Antiviral activity of marine biopolymers.Chapter 14: Potential anticoagulant effect of marine derived biopolymers.Chapter 15: Marine biopolymers for antiallergic therapeutics.

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Book SynopsisAqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of comTable of ContentsAqueous-based polymeric coating. Pseudolatex dispersions for controlled drug delivery. Processing and equipment considerations for aqueous-based coatings. Mechanical properties of polymeric films prepared from aqueous dispersions. Defects in aqueous film coated solid oral dosage form. Adhesion of polymeric films. Influence of insoluble additives on the properties of polymeric coating systems. Process and formulation factors affecting drug release from pellets coated with ethylcellulose pseudolatex Aquacoat. Chemistry and application properties of polymethacrylate systems. Application of HPMC and HPMCAS to aqueous film coating of pharmaceutical dosage forms. The applications of formulated systems for aqueous film coating of pharmaceutical solid oral dosage forms. *Substrate considerations when developing an aqueous film coated solid oral dosage form. Polymer interactions with drugs and excipients. Physical aging of polymers and it effect on the stability of solid oral dosage forms.

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Book SynopsisThis book covers the broad field of cellular, molecular, preclinical, and clinical imaging either associated with or combined with photodynamic therapy (PDT). It showcases how this approach is used clinically for cancer, infections, and diseases characterized by unwanted tissue such as atherosclerosis or blindness. Because the photosensitizers are also fluorescent, the book also addresses various imaging systems such as confocal microscopy and small animal imaging systems, and highlights how they have been used to follow and optimize treatment, and to answer important mechanistic questions. Chapters also discuss how imaging has made important contributions to clinical outcomes in skin, bladder, and brain cancers, as well as in the development of theranostic agents for detection and treatment of disease. This book provides a resource for physicians and research scientists in cell biology, microscopy, optics, molecular imaging, oncology, and drug discovery.Trade Review"The editors have skillfully compiled a wide and comprehensive spectrum from contributors around the world on up-to-date imaging technologies for photodynamic therapy (PDT), with a wealth of clinical images." –Optics & Photonics News"The editors have skillfully compiled a wide and comprehensive spectrum from contributors around the world on up-to-date imaging technologies for photodynamic therapy (PDT), with a wealth of clinical images." –Optics & Photonics NewsTable of ContentsINTRODUCTION. Looking out the optical window: Physical principles and instrumentation of imaging in photodynamic therapy. Photochemistry and photophysics of PDT and photosensitizers. IN VITRO MICROSCOPY FOR PHOTOSENSITIZER LOCALIZATION IN CELLS. Phthalocyanines in photodynamic therapy. Singlet oxygen luminescence imaging: A prospective tool in bioscience? Microbial biofilms and antimicrobial photodynamic therapy. High-content imaging for photosensitizer screening. IN VITRO MICROSCOPY OF CELL DAMAGE AND DEATH PROCESSES AFTER PDT. Enhanced efficacy of photodynamic therapy via an iron–lysosome–mitochondria connection: Studies with phthalocyanine 4. Role of cell death pathways in response to photodynamic therapy in gliomas. In search of specific PDT photosensitizers: Subcellular localization and cell death pathways. THERANOSTIC AGENTS AND NANOTECHNOLOGY. Quantum dots in PDT. Tetrapyrrole-based theranostic combinations of photodynamic action and magnetic resonance imaging. Theranostic applications of photodynamic molecular beacons. Tumor-specific imaging and photodynamic therapy targeting the urokinase receptor. SMALL ANIMAL IMAGING. Vascular imaging in photodynamic therapy. Photosensitizer activity imaging on the microscopic scale. Bioluminescence imaging for monitoring the effectiveness of photodynamic therapy for infections in animal models. CLINICAL IMAGING. Imaging of photosensitizers in skin. Brain tumor imaging with ALA. PDT of non-muscle-invasive bladder cancer with Hexylester Aminolevulinate: Optimization of the illumination wavelengths by fluorescence spectroscopy and imaging. Endoscopic imaging and photodynamic therapy. Spectroscopic imaging in prostate PDT. Fluorescent-guided resection in clinical oncology.

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Book SynopsisHydrogels are crosslinked, macromolecular polymeric materials arranged in a three-dimensional network, which can absorb and retain large amounts of water. Hydrogels are commonly used in clinical practice and experimental medicine for a wide range of applications, including drug delivery, tissue engineering and regenerative medicine, diagnostics, cellular immobilization, separation of biomolecules or cells, and barrier materials to regulate biological adhesions. This book elucidates the underlying concepts and emerging applications of hydrogels and will provide key case studies and critical analysis of the existing research.Table of ContentsMicroarchitecture of Water Confined in Hydrogels. The Fate of Thixotropy in Hydrogels. Hydrogel Network Parameters. Mechanisms of drug release from hydrogels in medical applications. Hydrogel Coatings for Medical Device Applications. Hydrogels for Bone Regeneration: An Overview. Hydrogels in Wound Management. Hydrogels for Imaging, Sensing and Diagnostics. Engineering Hyaluronan (HA) Hydrogels with Bioactive and Mechanical Signals. Hydrogel Nanomaterials for Cancer Diagnosis and Therapy. Thermosensitive Hydrogels for Drug Delivery and Tissue Engineering. Silk Hydrogels for Drug and Cell Delivery. In-Situ Forming Phase-inversion Injectable Hydrogels for Controlled Drug Release. Transdermal Applications of Hydrogels. Preparation of Photocurable Hydrogels. Stimuli-Responsive Biomolecular Hydrogels for Medical Applications. Bioengineering Complexity and Tuneability in Hydrogels. Synthetic hydrogels for 3D cell culture.

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Book SynopsisRegulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years. Research in Ayurveda is now a world-wide phenomenon, and several large pharmaceutical corporations are investing money for novel drug discovery from Ayurvedic sources. This book examines the regulatory and pharmacological aspects and includes extensive data on scientific evaluation carried out on Ayurvedic formulations. It will also serve as a reference book on standardization, pre-clinical studies, and clinical and toxicological studies on Ayurvedic formulations.Table of ContentsRegulatory Affairs in Ayurveda. Introduction to Regulatory Affairs. Introduction to Ayurvedic Pharmacopoeia of India. Drug Cosmetic Act and Ayurvedic Drugs. Ayurvedic Drug Manufacturing License. Good Manufacturing Practices for Ayurvedic, Siddha and Unani Medicines (SCHEDULE T). Ayurvedic Drug Industry. Pharmacovigilance of Ayurvedic Drugs. Heavy Metal Content of Ayurvedic Formulations. Genotoxicity of Ayurvedic Formulations. Aristolochic Acid Distribution in Ayurvedic Formulations. Patent and IPR Issues of Ayurvedic Formulations. Ayurvedic Nutraceuticals. Ayurvedic Cosmetics. Pharmacological Investigations on Ayurvedic Formulations. A-Z of Major Ayurvedic Formulations.

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Book SynopsisPraise for the first edition:Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this booknot only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC. -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regTrade Review "The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industrysponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the aspects of data safety monitoring committee (DMC) activities. A great feature of the book is the “DMCounselor” section at the end of each chapter, covering nearly 70 questions with answers, of which about 33% are for a DMC Chair, 30% for the DMC Biostatistician member, 30% for a DMC physician member, and the rest are for others (e.g., project manager)."~ Daniel Jia, Journal of Biopharmaceutical Statistics"Nicely written and readable cover-to-cover, the author walks through every facet of a Data Monitoring Committee (DMC) beginning with an overview of their past and current place in drug development, to how they are organized and interfaced with other committees, and on to the specifics of how a typical meeting is split into an open and closed session. From there it moves on to clinical issues, including how SAEs are categorized, statistical methods, including Bayesian and frequentist conditional power calculations, common biases and pitfalls, and guidance for how DMC decisions are made. It concludes with emerging issues due to new clinical trial designs mandated by the FDA to speed up the drug development process."~Donna Pauler Ankerst, BiometricsTable of ContentsPreface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.

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Book SynopsisComplete, Authoritative, Unrivaled CollectionClin-Alert, long established as the pre-eminent source of adverse drug reaction/interaction, now brings you Clin-Alert 2000. Presented in a quick reference format, Clin-Alert 2000 allows very easy access by drug class for comparison reports. Pharmacological classes are arranged based on a modified AHFS Therapeutic Classification Code System AND include the addition of a comprehensive section on alternative/herbal medicines.Table of ContentsDrug Classes Include: Alternative Therapies (herbals, supplements). Antihistamines. Anti-infective Agents. Anti-neoplastics. Autonomic Drugs. Blood Formation and Coagulation. Cardiovascular Drugs. CNS Agents (Analgesics, Sedatives, Psychotherapeutics). Dental Agents. Diagnostic Agents. Electrolytic and Water Balance. EENT Preparations. Gastrointestinal Agents. Hormones and Contraceptives. Radioactive Agents. Topical Products. Vaccines. Vitamins. Miscellaneous.

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Book SynopsisIn the fiercely competitive pharmaceutical marketplace, your organization cannot afford to spend excess dollars developing drugs that will fail to get FDA approval or have profoundly poor characteristics. Biochips as Pathways to Drug Discovery takes a comprehensive look at how the industry faces these challenges, using new technologies such as biochips to reduce the cost of drug discovery and improve drug safety. The book explores the tools and skills required at each step of the discovery process when using biochips to determine biological outcomes.The authors provide an in-depth review of the clinical and pharmacogenomic relevance of biochips, ChIP-chip assays, and high-throughput approaches. They discuss how biochips are used to develop biomarkers in the drug discovery process, primarily for gene expression profiling and Single Nucleotide Polymorphism (SNP) analysis. The book includes coverage of experimental theory, quality control, clinical laboratory sampling considerations, database concepts, industrial laboratory design, and the analysis of the resultant large data sets. It discusses the application of biochips to the study of malaria, toxicogenomics, and SNPs, as well as intellectual property and market overviews. The book concludes with a comprehensive overview of how these chips are employed from early target discovery through preclinical toxicology and on through to pharmacogenomic and proof of concept studies in humans. Written in an easily accessible style, the breadth of coverage introduces the subject to those new to the field, while the depth of coverage forms a foundation for future work. The book gives you the knowledge required to leverage the technology into bona fide discoveries. 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 authors of this volume provide an in-depth review of the clinical and pharmacogenomic relevance of biochips, ChIP-chip assays, and high-throughput approaches. … The book includes coverage of experimental theory, quality control, clinical laboratory sampling considerations, database concepts, industrial laboratory design, and the analysis of the resultant large data sets. … Written in an easily accessible style, the breadth of coverage introduces the subject to those new to the field, while the depth of coverage forms a foundation for future work.” — In Anticancer Research, Vol. 27, No. 3B, May/June 2007"This book is a must have for students who use biochips in their graduate work or others initiating efforts in these areas . . . In summary, Biochips as Pathways to Drug Discovery provides a broad yet detailed look at the use of DNA microarrays in drug discovery." – Matthew D. Disney, The University at Buffalo, The State University of New York, in ChemMedChem, 2008, No. 3Table of ContentsDNA Biochips — Past, Present, and Future: An Overview. Three-Dimensional HydroArrays: Novel Microarrays for Genomic and Proteomic Studies. Biochip in Malaria for Antiparasitic Discovery. Regional Variations in Intestinal ATP-Binding Cassette Transporter Expression Identified with a Global Error Assessment Model. Toxicogenomics in Drug Safety Evaluation: Bridging Drug Discovery and Development. The Next Generation of Automated Microarray Platforms for a Multiplexed CYP2D6 Assay. Biopsy and RNA Extraction Procedures of Muscle and Adipose Tissue for Microarray Gene-Expression Profiling. ChIP-on-Chip: Analysis of Genomewide Protein Binding and Posttranslational Modifications. DNA Microarrays as Functional Genomics Tools for Cancer Drug Discovery. High-Throughput Microarray Analysis. Laboratory Automation: Strategies for High-Volume Industrial Microarray Programs. Association Studies: Practical and Theoretical Considerations for Drug Discovery, Evaluation, and Beyond. Approaches for Microarray Data Validation. Microarray Enterprise Information Management: What Is It and Why Is It Important? Quality Control of Microarray Data. Microarray Data Normalization and Transformation. Amplification Strategies and DNA Biochips. Ribo-SPIA™, a Rapid Isothermal RNA Amplification Method for Gene Expression Analysis. Genomics, Transcriptomics, and Proteomics: Novel Detection Technologies and Drug Discovery. Intellectual Property Issues for DNA Chips and Microarrays. Biochips: Market Drivers and Commercial Prospect. A Pharmaceutical Perspective for Microarrays and Biochips: Current-Market Overview and Future Trends.

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