Medical laboratory testing and techniques Books
Jessica Kingsley Publishers Common Laboratory Tests Used by TCM
Book SynopsisTraditional Chinese Medicine (TCM) practitioners need to have an understanding of Western medical testing to recognize when laboratory tests are required and to interpret test results that are brought to them by patients. This book is an essential reference for the TCM classroom and clinic that teaches how to use and understand conventional lab testing in the treatment and referral of patients.Focusing on symptoms that commonly present in TCM practices, the book groups the lab tests by diseases or systems. Within each chapter are TCM case studies and perspectives, as well as multiple choice quizzes that test the reader's knowledge. Co-written by a doctor of Western medicine and an acupuncture physician, the book aims to familiarize TCM practitioners with the terminology and methodology of lab tests, bridging the gap between Eastern and Western schools of medicine and promoting an integrative approach to improve the overall care of the patient.Trade ReviewCommon Laboratory Tests Used by TCM Practitioners should be in every practitioner's office, every school library and part of acupuncture programs. The patient expects it. Society needs it. The book is arranged by disease and system. This approach is enhanced for learners with clear and pertinent background information which services the acupuncturist's needs perfectly. -- William R. Morris, PhD, DOAM, President, AOMA Graduate School of Integrative Medicine, Austin, TexasDoctors of TCM in China include two years of modern medical sciences as part of their training. They routinely order blood tests in the clinic to help with differential diagnosis, as well as monitoring the patient's prognosis using Chinese herbal medicine. As TCM practitioners in the West treat complicated internal disorders, it is important for them to understand conventional blood tests from other doctors, as well as order their own tests. Doctors Banerjee and Captain have written an extraordinary and thorough training manual on the use of common lab tests in a TCM practice. It is destined to become a standard text on the subject in our schools and clinics. -- Jake Paul Fratkin, OMD, L.Ac, author of Essential Chinese FormulasTable of ContentsPreface. 1. Complete Blood Count (CBC). 2. Hemoccult. 3. Kidney and Urine. 4. Electrolytes. 5. Glucose Metabolism and Diabetes Mellitus. 6. Liver Function. 7. Lipids. 8. Thyroid and Endocrinology. Practice Questions. Further Reading. Glossary.
£15.99
Wolters Kluwer Health The Only Diagnostic Lab Book Youll Ever Need
Book Synopsis Concise, conversational, entertaining, and easy to use at any level of healthcare experience, The Only Diagnostic Lab Book You’ll Ever Need clarifies the when, where, why, and how of laboratory testing to help you make informed testing decisions and draw confident clinical conclusions. This approachable how-to guide focuses on the most common and clinically useful diagnostic tests and panels employed in everyday healthcare practice, regardless of specialty, making it the ideal introduction for medical, PA, nurse practitioner, and nursing students embarking on their healthcare education. Residents, fellows, and practicing clinicians will find many new insights and clinical pearls that can immediately improve their practice and teaching. Straightforward, clinically oriented coverage walks you through selecting and employing the right diagnostic tests from the thousands available. The result is an informative, engaging text that will help you hone your clinical reasoning and streamline your approach to ordering and interpreting lab tests in the clinical decision-making process. Abundant illustrations, tables, and flow charts highlight key concepts in selecting and interpreting diagnostic lab tests. Lively, lighthearted text gets right to the point without compromising clarity or detail. Discussions emphasize what the tests actually mean within the relevant clinical context, stressing understanding over memorization; you will know what to do next, what to avoid, and why.
£50.39
Oxford University Press Cytopathology Fundamentals of Biomedical Science
Book SynopsisCytopathology provides a wide-ranging overview of the microscopic study of normal and abnormal cells, showing how current visualization methods are used to study cell structure, and how early detection of abnormal cell pathology can lead to timely clinical interventions.Trade ReviewReview from previous edition The flow of information is excellent and the text is well-written... a good introductory text for undergraduates with an interest in cytology and for professionals in training. * Dr Lesley Walton, School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University *Lucid, logical coverage of material, set out thoughtfully and supported by good illustrations and learning features that make the text student-friendly... a very useful undergraduate cytopathology textbook. * Dr Nicholas Vardaxis, Endeavour College of Natural Health *Clearly written, factual and concise. * Dr Patricia Gadsdon, FIBMS, School of Biological Sciences, Bangor University *Table of Contents1: Behdad Shambayati: Introduction: a glance at the past, a glimpse of the future 2: Andrew Evered & Behdad Shambayati: Preparation techniques 3: John Crossley & Beverley Crossley: The cervical screening process 4: Andrew Evered: Normal cervical cytology 5: Andrew Evered: Abnormal cervical cytology 6: John Crossley & Paul Cross: Quality issues in cervical screening and cytology 7: Andrew Evered: Diagnostic cytopathology 8: Behdad Shambayati: Cytology of urine 9: Behdad Shambayati: Serous effusions and peritoneal washings 10: Behdad Shambayati: Lower respiratory tract cytology 11: Behdad Shambayati: Fine needle aspiration cytology 12: Paul Cross & Behdad Shambayati: Cytology of head and neck 13: Stephen Blackman & Behdad Shambayati: Basic semen analysis 14: Behdad Shambayati: Cytology of the biliary tract and pancreas 15: Bruno Ping: Advances in cytopathology 16: Andrew Evered: Data analysis in cytopathology 17: Andrew Evered: Expertise in cytopathology
£55.09
American Society for Microbiology Clinical Microbiology Procedures Handbook,
Book Synopsis
£337.50
Oxford University Press Oxford Handbook of Clinical and Healthcare
Book SynopsisThis handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.Trade ReviewThe Oxford Handbook of Clinical and Healthcare Research packs a lot of information into a literally hand-sized ... book, with precise writing." * Norman M. Goldfarb, Journal of clinical research best practises *A unique handbook that covers all the stages of clinical research along with a clear description of the regulations / processes that current researchers need to comply with. This truly addresses a much needed gap in the various research handbooks. * Dr Puja Myles, Associate Professor Health Protection and Epidemiology; Nottingham University *Table of Contents1. Research - How and Why ; 2. Navigating Research Methods: Basic concepts in biostatistics and epidemiology ; 3. Navigating Research Methods: Quantitative and clinical / epidemiological methods ; 4. Navigating Research Methods: Qualitative methods ; 5. Navigating Research Methods: Evidence Based Medicine (EBM) ; 6. Navigating Research Methods: Critical ap-praisal ; 7. Navigating Research Methods: Clinical Audit ; 8. Setting the scene and ICH-GCP in clinical and healthcare research ; 9. Informed consent in a research setting ; 10. Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act ; 11. Role and Responsibilities: Investigators and Research Team ; 12. Role and Responsibilities: Sponsor ; 13. Monitoring ; 14. Clinical Trial Design ; 15. Clinical Trial Protocols: Study Protocol ; 16. Data Capture Tools: Case Report Form (CRF) ; 17. Clinical Trial Supplies: IMPs ; 18. IMP Accountability ; 19. Safety Reporting ; 20. Data management ; 21. Research Project Management ; 22. Essential Documents ; 23. Archiving ; 24. Audits and Inspections ; 25. Fraud and Misconduct ; 26. Authorship ; 27. Publication process ; 28. Start-up toolkit: from funding an idea, through implementation, to achieving an impact
£34.19
R F Hoke Phlebotomy
£16.19
Elsevier Science Publishing Co Inc Boormans Pathology of the Rat
Book SynopsisSuitable for researchers across science and medicine using rat models in the laboratory setting, this book offers an added emphasis on the Sprague-Dawley and Wistar rat strains, in line with research across academia, government and industry.Table of ContentsSection I: Digestive System Section II: Liver and Exocrine Pancreas Section III: Urinary Tract Section IV: Nervous System and Special Sense Organs Section V: Musculoskeletal System Section VI: Integumentary System Section VII: Mammary Gland Section VIII: Respiratory Tract Section IX: Immune System Section X: Bone Marrow Section XI: Female Reproductive Tract Section XII: Male Reproductive System Section XIII: Circulatory System Section IIV: Endocrine System Section IX: Historical Data
£179.10
Elsevier Health Sciences Laboratory Tests and Diagnostic Procedures
Book SynopsisCovers over 900 lab tests and diagnostic procedures in all. This title provides alphabetical list of hundreds of diseases, conditions, and symptoms, including the tests and procedures most commonly used to confirm or rule out a suspected diagnosis. It presents key information on virtually every laboratory and diagnostic test available.Table of ContentsHow to Use This Book Part I: Diseases, Conditions, and Symptoms Part II: Laboratory Tests and Diagnostic Procedures Appendix A: Reportable Diseases Appendix B: Informed Consent for Genetic Testing Bibliography
£39.59
Cardiotext Publishing Cardiac Electrophysiology , Second Edition: A
Book Synopsis
£99.75
Pearson Education (US) Pearson Handbook of Laboratory and Diagnostic
Book SynopsisJoyce LeFever Kee received her Bachelor of Science and Master of Science in Nursing degrees from the University of Maryland and earned 36 postgraduate credits from the University of Delaware. She was an instructor at the University of Maryland for 4 years and instructor to associate professor at the University of Delaware for 27 years, where she taught in both undergraduate- and graduate-level programs. She retired as Associate Professor Emerita from the University of Delaware. The subjects she taught included pharmacology, pathophysiology, fluid and electrolyte imbalances, and medical-surgical nursing in the classroom and clinical areas. Joyce is a member of the Sigma Theta Tau Nursing Honor Society and the Phi Kappa Phi Honor Society. She received the Excellence in Teaching Award from and was inducted into the Mentor's Circle at the University of Delaware. Kee has given numerous lectures and presentations throughout the United States from 1970 to 1990. She haTable of ContentsNotice of Privacy PracticesPreface AcknowledgmentsContributors and ConsultantsIntroductionDifferences in Reference Values Between Men and Women PART ONE: LABORATORY TESTS Considerations for Use of Laboratory Tests List of Laboratory Tests Laboratory Tests PART TWO: DIAGNOSTIC TESTS Considerations for Use of Diagnostic Tests List of Diagnostic Tests Diagnostic Tests PART THREE: SCHOOL HEALTH SERVICES: EDUCATION, SCREENING, AND TESTING PART FOUR: THERAPEUTIC DRUG MONITORING Appendix A: Health Problems with Laboratory and Diagnostic Tests Appendix B: Laboratory Test Values for Adults and Children Appendix C: CT and MRI Contrast Bibliography Index
£85.12
Penguin Putnam Inc Miracle Cure The Creation of Antibiotics and the
Book SynopsisThe epic history of how antibiotics were born, saving millions of lives and creating a vast new industry known as Big Pharma.As late as the 1930s, virtually no drug intended for sickness did any good; doctors could set bones, deliver babies, and offer palliative care. That all changed in less than a generation with the discovery and development of a new category of medicine known as antibiotics. By 1955, the age-old evolutionary relationship between humans and microbes had been transformed, trivializing once-deadly infections. William Rosen captures this revolution with all its false starts, lucky surprises, and eccentric characters. He explains why, given the complex nature of bacteria—and their ability to rapidly evolve into new forms—the only way to locate and test potential antibiotic strains is by large-scale, systematic, trial-and-error experimentation. Organizing that research needs large, well-funded organizations and busine
£14.40
Oxford University Press Histopathology Fundamentals of Biomedical Science
Book SynopsisHistopathology describes the processes and practices that are central to the role of the histopathologist within a functioning diagnostic laboratory, from pre-sampling to diagnosis to laboratory management.Trade ReviewIt is very simply and clearly written in language that is easy to understand for the non-specialist. It describes day-to-day histopathology lab practice with clarity and the case studies are very helpful to illustrate the applications of the techniques. * Susan Brooks, Oxford Brookes University *The strength of the book is its detail. The book contains information that is completely lacking from other histopathology books. Overall I think that it is a great textbook for biomedical students and academics. * Akis Karakesisoglou, Durham University *Any potential biomedical scientist with an interest in histopathology, and sound knowledge of the contents of this well- written and nicely-illustrated text together with appropriate practical experience would be well on their way to becoming a valuable member of the team that comprises the core of todays histopathology laboratory. The text will make a valuable addition to any library associated with laboratories performing histopathological techniques. * Judy Brincat, Histology Group of Victoria *Table of Contents1: Dr Guy Orchard, Mr David Muskett, Dr Anne Warren: What is histopathology? 2: Mr David Muskett: Fixation and specimen handling 3: Ms Vanda McTaggart, Dr Sue Pritchard, Dr Anne Warren: Data recording and histopathology dissection 4: Mr David Muskett: Routine staining, processing and embedding 5: Mr David Muskett and Dr Guy Orchard: Special stains 6: Dr Guy Orchard , Mrs Chantell Hodgson, Mr Brian Nation: Artefacts 7: Dr Guy Orchard and Mr Mohammad Shams: Mohs procedures 8: Dr Merdol Ibrahim and Dr Guy Orchard: Immunocytochemical techniques 9: Mr David Muskett, Dr Guy Orchard, Dr Anne Warren: Analytical immunocytochemistry 10: Dr Tony Warford and Dr Emanuela Volpi: In situ hybridization: concepts and applications 11: Mr Brendan O'Sullivan and Dr Phillipe Taniere: Molecular diagnostics: techniques and applications 12: Dr Phillipe Taniere: Molecular diagnostics in action 13: Dr Guy Orchard and Dr Sue Pritchard: Histopathology reporting 14: Dr Guy Orchard: Microscopy and digital pathology 15: Prof David Furness: Electron microscopy in diagnosis 16: Ms Ishbel Gall and Dr Mike Osborne: Mortuary practice 17: Ms Sue Alexandra and Ms Patricia Fernando: Essentials of laboratory management
£44.99
Oxford University Press Transfusion and Transplantation Science
Book SynopsisBiomedical scientists are the foundation of modern healthcare, from cancer screening to diagnosing HIV, from blood transfusion for surgery to food poisoning and infection control. Without biomedical scientists, the diagnosis of disease, the evaluation of the effectiveness of treatment, and research into the causes and cures of disease would not be possible.The Fundamentals of Biomedical Science series has been written to reflect the challenges of practicing biomedical science today. It draws together essential basic science with insights into laboratory practice to show how an understanding of the biology of disease is coupled to the analytical approaches that lead to diagnosis. Assuming only a minimum of prior knowledge, the series reviews the full range of disciplines to which a Biomedical Scientist may be exposedfrom microbiology to cytopathology to transfusion science.The science of transfusion and transplantation demands a multifaceted understanding of immunology, haematology, andTrade ReviewReview from previous edition Excellent teaching material for those studying Biomedical Science. * Dr Stephen F. Hughes, University of Chester *There is a clear focus on practical application of the theory in the transfusion lab. * Dr Christine Shirras, Lancaster University *The main strength is the Biomedical Science perspective. The emphasis is on transfusion practice within the laboratory: the biochemistry backs up the practical applications, not the other way round as biochemistry texts often do. * Trish Procter, Keele University *Table of Contents1: Neil D. Avent: Introduction to Basic Immunology and Techniques 2: Neil D. Avent: Human Blood Group Antigens 3: Neil D. Avent: Haemolytic Disease of the Fetus and Newborn 4: Lionel Mohabir: Clinical Use of Blood Components 5: Catherine Hyland, John Barbara, and Lionel Mohabir: Microbiological Testing of Blood Donations 6: Geoff Lucas: Human Platelet Antigens (HPA) and Human Neutrophil Antigens (HNA) and their Clinical Significance 7: Malcolm Needs: Compatibility Testing and Adverse Effects 8: Malcolm Needs: Immune Mediated Red Cell Destruction 9: Neil D. Avent: Human Leucocyte Antigens (HLA) and their Clinical Significance 10: Ruth Morse and Saeed Kabrah: Haematopoietic Stem Cell Transplantation and Stem Cell Plasticity 11: Richard Lomas, Neil D. Avent, and Vehid Salih: Tissue Banking 12: Joan Jones: Quality Issues
£38.99
Oxford University Press Molecular Diagnostics
Book SynopsisOne of the most notable trends in biomedical science in recent years has been the increasing use of molecular techniques as part of the diagnosis of disease. As such, there is a growing need for students to understand the technological basis of molecular analysis and to have a comprehensive appreciation of their use in diagnosis. Combining coverage of molecular techniques with their application to diagnostic pathology, this book provides students with a thorough and up to date appreciation of the scope of molecular analysis, the principles of the technology used, and thematic diagnostic application. As part of the Fundamentals of Biomedical Science series, the book provides a unique blend of theory and practice, featuring a range of learning features to help students assimilate the information presented quickly and effectively. It will be relevant to undergraduate students on a wide variety of biomedical pathways, cutting across traditional discipline boundaries to provide a unified ovTable of ContentsIntroduction 1: Sample preparation 2: The molecular laboratory 3: Intact sample analysis 4: Homogenate sample analysis 5: Sequencing technologies 6: Molecular analysis and interpreting molecular data 7: Recent technical advances in molecular analysis 8: Haemopoietic diseases 1 - leukaemias 9: Haemopoietic diseases 2 - lymphoproliferative disorders 10: Breast cancer 11: Epithelial tumours and melanoma 12: Mesenchymal tumours 13: Pre-natal and neo-natal testing
£47.99
Oxford University Press An Introduction to Clinical Trials
Book SynopsisAn Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the ultimate clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life.Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials.Table of Contents1: What is a clinical trial? 2: Designing a clinical trial 3: Randomised controlled trials 4: Alternative randomised controlled trials designs 5: Choosing the sample size for a clinical trial 6: Setting up a clinical trial 7: Data collection and monitoring in a clinical trial 8: Conducting a clinical trial 9: Analysing a clinical trial 10: Reporting and disseminating the findings of a clinical trial
£49.91
National Academies Press Guide for the Care and Use of Laboratory Animals
Book SynopsisA respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: *Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. *Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. *Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, Table of Contents1 Front Matter; 2 1 Key Concepts; 3 2 Animal Care and Use Program; 4 3 Environment, Housing, and Management; 5 4 Veterinary Care; 6 5 Physical Plant; 7 Addendum: Guide for the Care and Use of Laboratory Animals Eighth Edition; 8 Appendices; 9 Appendix A: Additional Selected References; 10 Appendix B: U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training; 11 Appendix C: Statement of Task; 12 Appendix D: About the Authors; 13 Index
£31.35
Elsevier Health Sciences Basic Applied Concepts of Blood Banking and
Book Synopsis
£74.69
John Wiley & Sons Inc Regulated Bioanalytical Laboratories
Book SynopsisThis book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also tTrade Review Table of ContentsPreface xiii Acknowledgment xvii Contributors and Advisors xix 1 Introduction, Objectives, and Key Requirements for GLP Regulations 1 1.1 Introduction 1 1.1.1 Good Laboratory Practices 1 1.1.2 Bioanalytical Laboratories—Bioanalysis 4 1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/ Bioanalysis 7 1.2 Objectives and Key Requirements for GLP Regulations 8 1.3 Fundamental Understanding of GLP Regulations and Principles 10 1.3.1 Elements of Good Laboratory Practices 11 1.4 Key Elements of Bioanalytical Methods Validation 16 1.4.1 Reference Standards 19 1.4.2 Method Development—Chemical/Chromatographic Assay 20 1.4.3 Calibration/Standard Curve 21 1.4.4 Stability 21 1.4.5 Reproducibility 23 1.4.6 Robustness or Ruggedness 23 1.5 Basic Principles of Bioanalytical Method Validation and Establishment 23 1.5.1 Specific Recommendations for Method Validation 24 1.5.2 Acceptance Criteria for Analytical Run 29 References 33 2 Historic Perspectives of GLP Regulations, Applicability, and Relation to Other Regulations 35 2.1 Historic Perspectives of GLP Regulations 35 2.1.1 Economic Assessment 39 2.1.2 Environmental Impact 40 2.2 Applicability and Relations to Other Regulations/Principles 42 2.2.1 GLP, GCP, GMP, and Part 11 42 2.2.2 General Terminologies and Definitions of GxPs (GLP, GCP, and cGMP) 47 2.3 Comparison of FDA GLP, EPA GLP Regulations, and OECD GLP Principles 47 2.3.1 US and OECD GLP Similarity and Differences 53 2.4 Applications of GLP to Multiple Site Studies 55 2.4.1 Roles and Responsibilities 57 2.4.2 Performance of the Studies 61 2.4.3 Applications of GLP to In Vitro Studies for Regulatory Submissions 64 2.5 21 CFR Part 11 in Relation to GLP Programs 66 2.5.1 A New Risk-Based Approach 67 2.5.2 Understanding Predicate Rule Requirements 67 2.5.3 21 CFR Part 11 Best Practices 68 2.5.4 Use of Electronic Signatures 71 2.6 GLP, cGMP, and ISO Applicabilities, Similarity, and Differences 74 2.6.1 GLPs, cGMPs, ISO 17025:2005: How Do They Differ? 74 2.6.2 GLPs Versus GMPs 74 2.6.3 GLPs Versus ISO/IEC 17025:2005 75 2.6.4 ISO Versus GLPs 76 2.7 Good Clinical Practices and Good Clinical Laboratory Practices 78 2.8 Gap and Current Initiatives on Regulating Laboratory Analysis in Support of Clinical Trials 80 References 84 3 GLP Quality System and Implementation 87 3.1 GLP Quality System 87 3.1.1 Regulatory Inspection for GLP Quality System 95 3.1.2 Good Laboratory Practice Inspections 99 3.1.3 GLP Quality System Objectives 103 3.2 Global GLP Regulations and Principles 106 3.2.1 General 106 3.2.2 Responsibilities and Compliance 107 3.2.3 Statement of Compliance in the Final Report 107 3.2.4 Protocol Approval 108 3.2.5 Assignment of Study Director 108 3.2.6 Laboratory Qualification/Certification 108 3.2.7 Authority Inspections 108 3.2.8 Archiving Requirements 108 3.3 Implementation of GLP Regulations and OECD Principles 109 3.3.1 Planning (Master Schedule) 114 3.3.2 Personnel Organization 115 3.3.3 Curriculum Vitae 115 3.3.4 Rules of the Conducts of Studies 116 3.3.5 Content of Study Protocol 116 3.3.6 Approval of Study Protocol 118 3.3.7 Distribution of Study Protocol 118 3.3.8 Protocol Amendment 118 3.3.9 Standard Operating Procedures 119 3.3.10 SOP System Overview 119 3.3.11 Characterization 121 3.3.12 Test Item/Article Control before Formulation 121 3.3.13 Preparation of the Dose Formulation 123 3.3.14 Sampling and Quality Control of Dose Formulation 125 3.4 Initiatives and Implementation of Bioanalytical Method Validation (Guidance for Industry BMV—May 2001) 126 3.4.1 Summary 127 References 128 4 Fundamental Elements and Structures for Regulated Bioanalytical Laboratories 131 4.1 Introduction 131 4.2 Fundamental Elements for Bioanalytical Laboratories 133 4.2.1 Document Retention and Archiving 136 4.3 Basic Requirements for GLP Infrastructure and Operations 139 4.4 GxP Quality Systems 143 4.4.1 Laboratory Instrument Qualification and Validation 149 4.4.2 Procedural Elements and Function that Maintain Bioanalytical Data Integrity for GLP Studies 150 References 166 5 Technical and Regulatory Aspects of Bioanalytical Laboratories 167 5.1 Fundamental Roles and Responsibilities of Bioanalytical Laboratories 167 5.1.1 Technical Functions of Bioanalytical Laboratories 168 5.1.2 Basic Processes in Bioanalytical Method Development, Validation, and Sample Analysis 173 5.2 Qualification of Personnel, Instrumentation, and Analytical Procedures 178 5.2.1 From Regulatory Perspectives: Personnel, Training, and Qualification 183 5.2.2 Facility Design and Qualifications 186 5.2.3 Equipment Design and Qualification 186 5.2.4 Analytical/Bioanalytical Method Qualification and Validation along with Related SOPs 197 5.3 Regulatory Compliance with GLP Within Bioanalytical Laboratories 204 5.4 Joint-Effort from Industries and Regulatory Agencies 206 5.4.1 Ligand-Binding Assays In-Study Acceptance Criteria 213 5.4.2 Determination of Metabolites during Drug Development 216 5.4.3 Incurred Sample Analysis 216 5.4.4 Documentation Issues 217 5.4.5 Analytical/Validation Reports 218 5.4.6 Source Data Documentation 218 5.4.7 Final Report Documentation 219 5.4.8 Stability Recommendation 219 5.4.9 Matrix Effects for Mass Spectrometric-Based Assays 221 5.4.10 System Suitability 222 5.4.11 Reference Standards 222 5.4.12 Validation Topics with No Consensus 222 5.4.13 Specific Criteria for Cross-Validation 223 5.4.14 Separate Stability Experiments Required at – 70°C if Stability Shown at – 20°C 223 5.4.15 Stability Criteria for Stock Solution Stability 224 5.4.16 Acceptance Criteria for Internal Standards 224 5.4.17 Summary 224 References 226 6 Competitiveness of Bioanalytical Laboratories—Technical and Regulatory Perspectives 229 6.1 Technical Aspect of Competitive Bioanalytical Laboratories 229 6.2 Bioanalytical Processes and Techniques 232 6.2.1 Sample Generation, Shipment, and Storage 232 6.2.2 Sample Preparation 233 6.3 Enhancing Throughput and Efficiency in Bioanalysis 243 6.3.1 Chromatographic Separation 244 6.3.2 Selective and Sensitive Detection 251 6.4 Technical Challenges and Issues on Regulated Bioanalysis 254 6.4.1 Matrix Effect 254 6.4.2 Method Validation and Critical Issues during Sample Analysis 256 6.4.3 Method Transfer 258 6.5 Regulatory Aspects of Competitive Bioanalytical Laboratories 264 6.5.1 General Consideration 264 6.5.2 Historical Perspective 265 6.5.3 Personnel—Training and Qualification 267 6.5.4 Facility—Design and Qualifications 269 6.5.5 Equipment Design and Qualification 270 6.5.6 Standard Operating Procedures 272 6.5.7 Laboratory/Facility Qualification Perspectives 272 6.6 Advanced/Competitive Bioanalytical Laboratories 277 6.6.1 Strategy Versus Tactics 278 6.6.2 Bioanalytical Laboratory Assessment 279 6.6.3 Capacity 279 6.6.4 Experience 280 6.6.5 Quality 281 6.6.6 Performance and Productivity Measures 281 6.6.7 Information Technology and Data Management 282 6.6.8 Communication 282 6.6.9 Financial Stability 283 6.6.10 Ease of Use 283 6.6.11 Contracting Bioanalytical Services 284 6.6.12 The Contracting Process 284 6.7 Applications and Advances in Biomarker and/or Ligand-Binding Assays within Bioanalytical Laboratories 286 References 290 7 Sponsor and FDA/Regulatory Agency GLP Inspections and Study Audits 297 7.1 GLP versus Biomedical Research Monitoring and Mutual Acceptance of Data for Global Regulations and Inspections 298 7.2 Purposes and Benefits of Regulatory Inspections/Audits 303 7.2.1 Criteria for Selecting Ongoing and Completed Studies 304 7.2.2 Areas of Expertise of the Facility 305 7.2.3 Establishment Inspections 305 7.2.4 Organization and Personnel (21 CFR 58.29, 58.31, 58.33) 305 7.2.5 Quality Assurance Unit (QAU; 21 CFR 58.35) 307 7.2.6 Facilities (21 CFR 58.41–58.51) 308 7.2.7 Equipment (21 CFR 58.61–58.63) 309 7.2.8 Testing Facility Operations (21 CFR 58.81) 310 7.2.9 Reagents and Solutions (21 CFR 58.83) 311 7.2.10 Animal Care (21 CFR 58.90) 311 7.2.11 Test and Control Articles (21 CFR 58.105–58.113) 312 7.2.12 Test and Control Article Handling (21 CFR 58.107) 313 7.2.13 Protocol and Conduct of Nonclinical Laboratory Study (21 CFR 58.120–58.130) 314 7.2.14 Study Protocol (21 CFR 58.120) 314 7.2.15 Test System Monitoring 314 7.2.16 Records and Reports (21 CFR 58.185–58.195) 314 7.2.17 Data Audit 316 7.2.18 General 316 7.2.19 Final Report Versus Raw Data 317 7.2.20 Specimens Versus Final Report 318 7.2.21 Refusal to Permit Inspection 318 7.2.22 Sealing of Research Records 318 7.2.23 Samples 319 7.3 Typical Inspections/Audits and Their Observations 320 7.4 Regulatory Challenges for Bioanalytical Laboratories 321 7.4.1 Introduction 321 7.4.2 Analysis of Current FDA Inspection Trends 324 7.4.3 Discussion and Analysis of Specific Potential FDA 483 Observation Issues 325 7.4.4 Method Validation Issues 325 7.4.5 Batch Runs Acceptance Criteria Issues 329 7.4.6 Events/Deviations Investigation/Resolution Issues 331 7.4.7 Test Specimen Accountability Issue 333 7.4.8 Recommendations to Support an Effective FDA Inspection Readiness Preparation 334 7.5 Handling and Facilitating GLP or GxP Audits/ Inspections 334 7.5.1 General Preparation for an Inspection 336 7.5.2 Why Are Audits/Inspections Needed and Conducted? 342 7.5.3 Written Policy in Place 342 7.5.4 Positions on Controversial Issues 343 7.5.5 The Inspection Coordinator 344 7.5.6 Follow-Up Procedures 348 7.5.7 Summary 349 References 351 8 Current Strategies and Future Trends 353 8.1 Strategies from General Laboratory and Regulatory Perspectives 354 8.2 Strategies from Technical and Operational Perspectives 356 8.3 Biological Sample Collection, Storage, and Preparation 360 8.3.1 Sample Collection and Storage 360 8.3.2 Sample Preparation Techniques 361 8.3.3 Off-Line Sample Extraction 364 8.3.4 On-Line Sample Extraction 364 8.4 Strategies for Enhancing Mass Spectrometric Detection 366 8.4.1 Enhanced Mass Resolution 368 8.4.2 Atmospheric Pressure Photoionization 369 8.4.3 High-Field Asymmetric Waveform Ion Mobility Spectrometry 370 8.4.4 Electron Capture Atmospheric Pressure Chemical Ionization 370 8.4.5 Mobile Phase Optimization for Improved Detection and Quantitation 371 8.4.6 Anionic and Cationic Adducts as Analytical Precursor Ions 372 8.4.7 Derivatization 372 8.5 Strategies for Enhancing Chromatography 374 8.5.1 Ultra-Performance Chromatography 375 8.5.2 Hydrophilic Interaction Chromatography for Polar Analytes 376 8.5.3 Specialized Reversed-Phase Columns for Polar Analytes 377 8.5.4 Ion-Pair Reversed-Phase Chromatography for Polar Analytes 378 8.6 Potential Pitfalls in LC–MS/MS Bioanalysis 378 8.6.1 Interference from Metabolites or Prodrugs due to In-Source Conversion to Drug 378 8.6.2 Interference from Metabolites or Prodrugs due to Simultaneous M + H+ and M + NH4+ Formation or Arising from Isotopic Distribution 379 8.6.3 Pitfall in Analysis of Two Interconverting Analytes due to Inappropriate Method Design 383 8.6.4 Matrix Effect 383 8.7 Trends in High-Throughput Quantitation 386 8.7.1 System Throughput 386 8.7.2 High-Speed HPLC 386 8.8 Trends in Hybrid Coupling Detection Techniques 388 8.9 Trends in Internal R&D and External Outsourcing 388 8.10 Trends in Ligand-Binding Assays and LC–MS/MS for Biomarker Assay Applications 397 8.11 Trends in Study Design and Evaluation Relating to Bioanalysis 399 8.12 Trends in Applying GLP to In Vitro Studies in Support of Regulatory Submissions 403 8.13 Trends in Global R&D Operations 404 8.14 Trends in Regulatory Implementations 407 8.14.1 Calibration Range and Quality Control Samples 407 8.14.2 Incurred Sample Reproducibility (Duplicate Sample Analysis) 408 8.14.3 LIMS and Electronic Data Handling, Security, Archiving, and Submission 409 8.15 Trends in Global Regulations and Quality Standards 412 8.16 Trends in Compliance with 21 CFR Part 11 414 8.16.1 21 CFR Part 11 Software Requirements 415 8.16.2 Building a Roadmap for Compliance with 21 CFR Part 11 415 8.16.3 Low Hanging Fruits in the Roadmap for Compliance with 21 CFR Part 11 416 8.17 Summary 419 References 421 9 General Terminologies of GxP and Bioanalytical Laboratories 431 9.1 General Terminologies for GxP and Bioanalytical Laboratories 431 9.2 GLP Basic Concepts and Implementation 469 9.2.1 The Study Protocol 470 9.2.2 Raw Data 471 9.2.3 The GLP Archive and the Archivist 472 9.2.4 Expansion of GLP Scope 473 9.2.5 OECD GLP 473 9.3 GLP Guidance Documents 474 9.3.1 FDA Guidance for Industry on Bioanalytical Method Validation 474 9.3.2 OECD GLP Guidance Documents 474 9.3.3 Swiss GLP Guidance Documents 475 References and Sources for Above Terminologies 475 Appendix A Generic Checklist for GLP/GXP Inspections/Audits 479 Appendix B General Template for SOP 489 Appendix C Typical SOPs for GLP/Regulated Bioanalytical Laboratory 493 Quality Assurance—GLP 493 Bioanalytical—GLP Laboratories 494 Appendix D Basic Equipment/Apparatus for Bioanalytical Laboratory 497 Appendix E Website Linkages for Regulated Bioanalysis 499 Index 503
£119.65
John Wiley & Sons Inc Drug Discovery and Development Volume 2 Drug
Book SynopsisThis two volume set provides a comprehensive account of the entire sequence of operations involved in discovering a drug through the actual delivery of the drug to clinicians and medical practitioners.Table of ContentsContributors. Preface. 17 Bioactive Molecules in Medicinal Plants: A Perspective on Their Therapeutic Action (S. C. Taneja and G. N. Qazi). 17.1 Introduction. 17.2 Evolutionary Relationships Among Plants and Humans. 17.3 Traditional Wisdom. 17.4 Unique Libraries for Plants. 17.5 Drugs and Bioactive Molecules from Plants. 17.6 Synergism in Herbal Formulations. 17.7 Interactions Between Modern Drugs and Natural Products. 17.8 Bioavailability and Bioeffi cacy Enhancers. 17.9 Combination Therapies in Modern Drugs. 17.10 Role of Developments in Technologies and Analytical Tools. 17.11 Herbal Medicine: The Best Possible Route to Health Care. References. 18 Natural Products as an Inspiration for the Discovery of New High-Throughput Chemical Synthesis Tools (Steven V. Ley, Ian R. Baxendale, Deborah A. Longbottom, and Rebecca M. Myers). 18.1 Introduction. 18.2 Solid-Supported Reagents as Tools in Natural Product Synthesis. 18.3 Multistep Use of Supported Reagents in Natural Product Synthesis. 18.4 Conclusions. References. 19 Insulin Sensitizers: Emerging Therapeutics (Braj B. Lohray and Vidya B. Lohray). 19.1 Introduction. 19.2 Therapeutic Interventions. 19.3 Discovery of Insulin Sensitizers. 19.4 Journey Toward New Drugs. 19.5 Conclusions. References. 20 Criteria for Industrial Readiness of Chiral Catalysis Technology for the Synthesis of Pharmaceuticals (Raymond McCague and Ian C. Lennon). 20.1 Introduction. 20.2 Criteria for Technology Readiness. 20.3 Examples of Industrially Ready Chiral Catalytic Technologies and Their Application. 20.4 How Industrially Ready Technology Can Deliver Commercial Advantages. 20.5 Conclusions. References. 21 Enantioselective Synthesis of Propargyl Alcohols as Multifunctional Synthons (J. S. Yadav and S. Chandrasekhar). 21.1 Introduction, 141 21.2 Asymmetric Reduction of Prochiral α, β-Alkynyl Ketones, 142 21.3 Addition of Acetylenic Anion to Carbonyl Carbon, 148 21.4 Desymmetrization and Enzymatic Strategies for Chiral Propargyl Alcohol Synthesis. 21.5 β-Elimination Strategy and Miscellaneous Approaches. 21.6 Conclusions. References. 22 Carbohydrates: From Chirons to Mimics (G. V. M. Sharma and Palakodety Radha Krishna). 22.1 Introduction. 22.2 Synthetic Strategies for C-Glycosides. 22.3 Synthetic Strategies for Carbon-Linked Disaccharides and Pseudosaccharides. References. 23 Meeting the Challenges of Process Development and Scale-up of Active Pharmaceutical Ingredients (Yatendra Kumar and B. Vijayaraghavan). 23.1 Introduction. 23.2 Process Development Cycle. 23.3 Conclusions. References. 24 Importance of Polymorphs and Salts in the Pharmaceutical Industry (Bipin Pandey, Vidya B. Lohray, and Braj B. Lohray). 24.1 Introduction. 24.2 Drug Discovery and Development. 24.3 Salt Selection. 24.4 Pseudopolymorphs. 24.5 Analytical Tools. 24.6 Process Development. 24.7 Formulation Development. 24.8 Regulatory Concerns. 24.9 Patent Implications. 24.10 Predictions and Uncertainties. 24.11 Conclusions. References. 25 Role of Outsourcing in Drug Manufacture (Peter Pollak). 25.1 Introduction. 25.2 Outsourcing in the Pharmaceutical Industry. References. 26 Regulation-Driven Process Chemistry (Shrikant V. Kulkarni). 26.1 Introduction. 26.2 Chemical Industry Regulatory Guidelines. 26.3 Manufacturing Techniques in Process Chemistry. 26.4 Effects of Pesticide Industry Regulation. 26.5 Efforts at Denitrifi cation. 26.6 Evolution to Green Chemistry. References. 27 Chemical Process Scale-up Tools: Mixing Calculations, Statistical Design of Experiments, and Automated Laboratory Reactors (Andrei A. Zlota). 27.1 Chemical Process Scale-up Challenges. 27.2 Case Study: Development of an Active Pharmaceutical Ingredient Crystallization Process. 27.3 Case Study: Determination of a Scale-up Factor for the Bourne III Reactive System. 27.4 Conclusions. References and Notes. 28 Library Quality Metrics (Richard L. Wife and Johan Tijhuis). 28.1 Drug Discovery and Development. 28.2 Compound Libraries. 28.3 Library Metrics. 28.4 Conclusions. 29 Tying a GABA from Copenhagen to Chicago: The Chemistry of Tiagabine (Mukund S. Chorghade, Mahendra N. Deshpande, and Richard J. Pariza). 29.1 Introduction. 29.2 Synthesis of Symmetrical Analogs: Tiagabine. 29.3 Synthesis of Unsymmetrical Analogs: Desmethyltiagabine. 29.3.1 Syntheses of Regioisomers of Tiagabine. 29.3.2 Human Metabolite of Tiagabine: 5-Hydroxytiagabine. 29.4 Attempted Biomimetic Synthesis of 5-Hydroxytiagabine. 29.5 Oxidative Degradation Products of Tiagabine. 29.6 Metalloporphyrins as Chemical Mimics of Cytochrome P450 Systems. References. 30 Building Contract Research Businesses Based on Integration of Basic and Applied Research (Mukund S. Chorghade, Mukund K. Gurjar, C. V. Ramana, and Sreenivas Punna). 30.1 Introduction. 30.2 Solving Real-World Problems. 30.3 Synthesis of Pharmaceutically Relevant Chiral Tetrahydrofurans. 30.4 Drugs for the Treatment of Skin Disorders. 30.5 Conclusions. References. 31 Principles and Practice of Clinical Drug Development (Colin Scott). 31.1 Introduction. 31.2 History of Ethical Medical Research. 31.3 History of the Regulation of Medical Research. 31.4 Preclinical Development. 31.5 Clinical Development. 31.6 Conclusions. Index.
£121.46
John Wiley & Sons Inc Drug Discovery and Development Volume 1
Book SynopsisVolume 1: Drug Discovery thoroughly describes conceptualizing a drug, creating a library of candidates for testing, screening those candidates for in vitro and in vivo activity, conducting and analyzing the results of clinical trials, and revising the drug as necessary.Trade Review"...provides a nice survey of most of the key topics facing discovery houses today." (Doody's Health Services) "This reasonably priced book is well-written and produced. It has a useful 32-page index, and it may be considered for acquisition by individuals and libraries." (Journal of Medicinial Chemistry, October 5, 2006)Table of ContentsContributors. Preface. 1. From Patent to Prescription: Paving the Perilous Path to Profit (Richard J. Pariza). 2. Medicinal Chemistry in the New Millennium: A Glance into the Future (Paul W. Erhardt). ADMET-Related Synergies, 59 3. Contemporary Drug Discovery (Lester A. Mitscher and Apurba Dutta). 4. Combinatorial Chemistry in the Drug Discovery Process (Ian Hughes). 5. Parallel Solution-Phase Synthesis (Norton P. Peet and Hwa-Ok Kim). 6. Timing of Analog Research in Medicinal Chemistry (János Fischer and Anikó Gere). 7. Possible Alternatives to High-Throughput Screening (Camille G. Wermuth). 8. Proteomics and Drug Discovery (Susan Dana Jones and Peter G. Warren). Appendix: Public-Domain Software Tools and Databases. 9. Using Drug Metabolism Databases During Drug Design and Development (Paul W. Erhardt). 10. Discovery of the Antiulcer Drug Tagamet (C. Robin Ganellin). 11. Discovery of Potent Nonpeptide Vasopressin Receptor Antagonists (Bruce E. Maryanoff). 12. Discovery and Development of the Ultrashort-Acting Analgesic Remifentanil (Paul L. Feldman). 13. Discovery and Development of Nevirapine (Karl Grozinger, John Proudfoot, and Karl Hargrave). 14. Applications of Nuclear Imaging in Drug Discovery and Development (John W. Babich and William C. Eckelman). 15. Polymeric Sequestrants as Nonabsorbed Human Therapeutics (Pradeep K. Dhal, Chad C. Huval, and S. Randall Holmes-Farley). 16. Botanical Immunomodulators and Chemoprotectants in Cancer Therapy (Bhushan Patwardhan, Sham Diwanay, and Manish Gautam). Index.
£132.95
John Wiley & Sons Inc Pharmaceutical Ethics Medical Sciences
Book SynopsisProvides ethical guidelines much needed by the pharmaceutical industry. This book covers ethical issues involved in the testing and use of pharmaceuticals on humans, focusing on the issues surrounding the pharmaceutical industry and not medicine in general.Trade Review"...it will give the uninitiated a feel for the range of ethical isues..." (Mental Health Care, February 2003) "...a good introduction to the ethics surrounding pharmaceuticals..." (Pharmaceutical Physician, March 2003) "...the core question: should you read this book...definitely yes...the book stimulates our thinking and helps the reader to define and outline the many dilemmas in health care..." (Pharm World Sci, Vol. 25, No. 2, 2003)Table of ContentsList of Contributors. Preface. Foreword. 1. The Basis of Ethics (Jon Merrills). 2. Principles of Ethics Focusing on the Patient (Andrew Edgar). 3. Ethical Rationalism Applied to Pharmaceuticals (R.P. Dessing). 4. The Etihcs of the Drug Discovery and Development Process (Roger G. Bolton). 5. Informed Conset: Reconsideration of its Structure and Role in Medicine (Jan Payne). 6. Clinical Trials of Pharmaceuticals: Ethical Aspects (Olivier Chassany, Martin Duracinsky and Isabelle Mahé). 7. Can We Afford the Medicines We Need: An Ethical Dilemma? (Roger Walker). 8. Physician Choice or Patient Choice: Ethical Dilemmas in Science and Politics (Andrew Edgar). 9. The Economics of Drug-Related Morbidity and Mortality: Ethical Considerations (J. Lyle Bootman and Amy J. Grizzle). 10. Holistic Approach in Choice of Pharmaceutical Agents: Ethical Responsibilities (Sam Salek). 11. Ethical Values in the Treatment of Depression and Anxiety (John Lilja, Sam Larsson, David Hamilton and Mia Bauer). 12. Ethical Promotion and Advertising of Medicines: Where Do We Draw the Line? (Ivor Harrison). 13. Ethical Problems of Drug Categorization for Reimbursement (Chris Good). Index.
£113.36
John Wiley & Sons Inc Biocompatiblity
Book SynopsisThis book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.Table of ContentsBiocompatibility Standards: An International Overview (D. Marlowe, et al.). The Role of Material Standardisation and Method Validation in Evaluating Biocompatibility (J. Braybrook). Biodegradation and Toxicokinetic Studies (D. Gott). The Surface Analysis of Polymeric Biomaterials (M. Davies, et al.). Sterilisation Processes and Residuals (V. Dorman-Smith). Cytotoxicity (M.-F. Harmand, et al.). Interactions with Blood (J. Anderson). Genotoxicity, Carcinogenicity and Reproductive Toxicity (R. Eloy & N. Weill). Explant Retrieval and Analysis (J. Butany). Assessment of Biological Safety - Risk Analysis (J. Tinkler). Index.
£207.86
Cambridge University Press Cowan and Steels Manual for the Identification of Medical Bacteria
Book SynopsisEssentially a practical manual with up-to-date contributions and key references by experts to the diagnostic characteristics of the bacteria likely to be encountered in public health and hospital microbiology laboratories as well as in medical and veterinary practice.Trade Review'In conclusion this excellent book has retained the best of the old and combined it with the new. It is a must for every clinical laboratory and at only £40, represents excellent value for money.' Tim Wyatt, Association of Clinical Microbiologists News'… this practical manual, which has been the standard diagnostic text since the mid-1960s, continues to be the standard reference text for bacteriology.' The Bulletin of The Royal College of PathologistsTable of ContentsForeword; Introduction; 1. Classification and nomenclature; 2. Culture media: constituents and sterilization; 3. Principles of isolation; 4. Bacterial characters and characterization; 5. Theory and practice of bacterial identification; 6. Characters of Gram-positive bacteria; 7. Characters of Gram-negative bacteria; 8. Taxonomy in theory and practice; 9. Bacterial identification by cards; 10. Bacterial identification by computer; 11. Quality control in microbiology; 12. Reconciliation of approaches to bacterial systematics; Glossary; References; Index.
£89.99
Cambridge University Press District Laboratory Practice in Tropical
Book SynopsisThis practical bench manual has been produced to help those working in the district laboratory, and those responsible for the organization and management of community laboratory services and the training of district laboratory personnel.Trade ReviewReview of District Laboratory Practice in Developing Countries Part 1: 'Clear and easily understood information is provided on the clinical biochemistry of laboratory analytes and the biology of parasites … The book is probably the most comprehensive source of information available today to those who work in or need to know about laboratory services in developing countries. It can be recommended as a basic document for laboratory technicians, technologists, and medical doctors at all levels …' Bulletin of the World Health OrganizationTable of ContentsPreface; 1. Organization and staffing of district laboratory services; 2. Total quality management of district laboratory services; 3. Health and safety in district laboratories; 4. Equipping district laboratories; 5. Parasitological tests; 6. Clinical chemistry tests; Appendix I. Preparation of reagents; Appendix II. Useful addresses; Appendix III. Useful charts and figures; Supplement. Planning a training curriculum for district laboratory personnel; Index.
£123.00
Elsevier Health Sciences Dacie and Lewis Practical Haematology
Book SynopsisTrade Review"It remains the worldwide standard in laboratory haematology and no haematologist should be without it!" "This is an excellent book for new learners or for experienced practitioners wanting an update/refresher. If you want a basic book covering all aspects of laboratory and clinical hematology, this is the one for you. If you are a student, this is a must have." -Valerie L. Ng, PhD MD (Alameda County Medical Center/Highland Hospital) Doody's Score: 94 - 4 Stars!Table of Contents1 Collection and handling of blood 2 Reference ranges and normal values 3 Basic haematological techniques 4 Preparation and staining methods for blood and bone marrow films 5 Blood cell morphology in health and disease 6 Supplementary techniques including blood parasite diagnosis 7 Bone marrow biopsy 8 Molecular and cytogenetic analysis 9 Iron deficiency anaemia and iron overload 10 Investigation of megaloblastic anaemia: cobalamin, folate and metabolite status 11 Laboratory methods used in the investigation of the haemolytic anaemias 12 Investigation of the hereditary haemolytic anaemias: membrane and enzyme abnormalities 13 Acquired haemolytic anaemias 14 Investigation of variant haemoglobins and thalassaemias 15 Erythrocyte and leucocyte cytochemistry 16 Immunophenotyping by flow cytometry 17 Diagnostic radioisotopes in haematology 18 Investigation of haemostasis 19 Investigation of a thrombotic tendency 20 Laboratory control of anticoagulant, thrombolytic and antiplatelet therapy 21 Blood cell antigens and antibodies: erythrocytes, platelets and neutrophils 22 Laboratory aspects of blood transfusion 23 Approach to the diagnosis and classification of blood cell disorders 24 Laboratory organisation, management and safety 25 Quality assurance 26 Haematology in under-resourced laboratories
£71.99
Taylor & Francis Ltd Handbook of PreClinical Continuous Intravenous Infusion
Book SynopsisAny scientist or technician involved in pre-clinical drug studies knows that infusing animal models with test substances is no simple matter, especially if one wants to do it humanely as well as guarantee results that are not compromised by the procedure. The challenge becomes compounded if one is employing a variety of species. What works for a rat or mouse does not necessarily work for a rabbit or primate. The Handbook of Pre-clinical Continuous Intravenous Infusion answers the needs of researchers and technicians by providing complete instructions for a wide range of infusion techniques delivered to several species. With sections devoted to rats, mice, rabbits, dogs, mini-pigs, and nonhuman primates (both large and small), this thorough text gives step-by-step instructions for the use of a variety of techniques, and equipment. It includes procedures for multidose infusion toxicity and reproductive toxicology studies, and provides guidance on the use of a variety of equipmentTrade Review"…an excellent buy for anyone involved in drug development, risk assessment or within drug licensing agencies and in academic research. …This book represents a benchmark achievement for this technique …it will become the standard for many years to come" British Toxicology Society Newsletter Table of ContentsIntroduction. Femoral Cannulation Using the Jacket/Harness Model in the Rat. Femoral Cannulation Using the Tail Cuff Exteriorisation Method in the Rat. Tethering and the Implanted Button Model in the Rat. Multidose Infusion Toxicity Studies in the Rat. Reproductive Infusion Toxicity Studies in the Rat. Femoral Cannulation Using the Tail Cuff Model in the Mouse. Multidose Infusion Toxicity Studies in the Mouse. Jugular Cannulation and Efficacy Studies in the Mouse. Femoral Cannulation of the Rabbit for Reproductive Toxicity Studies. Jugular Cannulation of the Rabbit for Reproductive Toxicity Studies. Jugular Cannulation of the Dog. The Non-Ambulatory Model in Dog Multidose Infusion Toxicity Studies. The Ambulatory Model in Dog Multidose Infusion Toxicity Studies. Surgical Preparation of the Large Primate. Multidose Infusion Toxicity Studies in the Large Primate. Surgical Preparation and Multidose Infusion Toxicity Studies in the Marmoset. Surgical Preparation of the Mini-Pig. Multidose Infusion Toxicity Studies in the Mini-Pig. Reproductive Toxicity Studies in the Mini-Pig. Common Pathological Findings in Continuous Infusion. The Use of Mini-Osmotic Pumps in Continuous Infusion Studies. The Contribution of Vehicles, Rates of Administration and Volumes to Infusion Studies. Equipment for Continuous Intravenous Infusion.NTI/Sales Copy
£125.86
Institute of Physics Publishing Advances in Drug Delivery Systems for Healthcare
Book Synopsis
£108.00
John Wiley & Sons Inc BioMedical Telemetry
Book SynopsisTable of ContentsPreface to the Second Edition. Preface to the First Edition. Introduction. Electronics. Modulation Including Blocking Oscillation. Plastics and Other Materials. Pressure Sensing and Transmission. Temperature Sensing and Transmission. Bioelectric and Chemical Electrode Potentials. Multichannel Transmission and Fetal Studies. Sensors and Transmitters for Other Variables. Frequency and Antenna Selection. Receivers and Demodulators. Calibration and Response Control. Passive Transmission. Field Work. Aquatic Animals. Inward Power and Telestimulation. Related Methods. Zoo Exhibits. Human Studies and Clinical Applications. Appendix 1: Antenna Turns. Appendix 2: Frequency Choice. Appendix 3: Legal Factors. Appendix 4: Laboratory Experiment on Transmitter Construction. Appendix 5: Phaselock Loop Receiver. Appendix 6: Stable Temperature-Compensated Oscillator. References. General Reading. Index. About the Author.
£170.96
F.A. Davis Company Molecular Diagnostics Fundamentals Methods and
Book SynopsisMeet the challenges of this rapidly expanding field with a solid understanding of the fundamentals of nucleic acid biochemistry as well as the advanced concepts integral to practice in today's laboratories. The third edition of this popular resource encompasses microbiology, virology, genetics, oncology, and human identification.Table of Contents I. Fundamentals of Molecular Biology: An Overview 1. Nucleic Acids and Proteins 2. Gene Expression and Epigenetics II. Common Techniques in Molecular Biology 3. Nucleic Acid Extraction Methods 4. Resolution and Detection of Nucleic Acids 5. Analysis and Characterization of Nucleic Acids and Proteins 6. Nucleic Acid Amplification 7. Chromosomal Structure and Chromosomal Mutations 8. Gene Mutations 9. DNA Sequencing III. Techniques in the Clinical Laboratory 10. DNA Polymorphisms and Human Identification 11. Detection and Identification of Microorganisms 12. Molecular Detection of Inherited Diseases 13. Molecular Oncology 14. DNA-Based Tissue Typing 15. Quality Assurance and Quality Control in the Molecular Laboratory Appendices A. Study Questions Answers B. Answers to Case Studies Glossary Index
£91.85
F.A. Davis Company The Phlebotomy Textbook
Book SynopsisPresents up-to-date coverage of routine procedures and their complications as well specialized procedures, quality and infection control, state-of-the-art equipment, medical terminology, ethical and legal issues, body systems, and related diagnostic laboratory tests. Videos, animations, and review questions online help you to excel.Table of Contents PART ONE PHLEBOTOMY AND THE HEALTHCARE FIELD 1. Phlebotomy and the Healthcare Delivery System 2. The Clinical Laboratory 3. Safety and Infection Control PART TWO BODY SYSTEMS 4. Basic Medical Terminology 5. Basic Anatomy and Physiology 6. The Circulatory System PART THREE PHLEBOTOMY TECHNIQUES 7. Venipuncture Equipment 8. Routine Venipuncture 9. Pre-examination Variables and Venipuncture Complications 10. Special Blood Collection 11. Dermal Puncture 12. Arterial Blood Collection PART FOUR ADDITIONAL TECHNIQUES 13. Point-of-Care Testing 14. Additional Duties of the Phlebotomist PART FIVE QUALITY PHLEBOTOMY 15. Ethical and Legal Issues 16. Quality Management in Phlebotomy APPENDIX A: Common Laboratory Tests and the Collection Tube Requirements APPENDIX B: Answers to Study Questions APPENDIX C: Answers to Clinical Situations APPENDIX D: Abbreviations APPENDIX E: English-Spanish Phrases for Phlebotomy GLOSSARY INDEX
£64.80
F.A. Davis Company Phlebotomy Notes
Book SynopsisCoverage includes concise procedural steps with photos; descriptions of venipuncture, dermal puncture techniques, and arterial puncture; information on safety issues and regulations, specimen requirements and clinical correlation, and pre-examination variables; and coverage of order of draw process.Table of Contents Tab 1 Safety Tab 2 Equipment Tab 3 Routine Venipuncture Tab 4 Venipuncture Complications Tab 5 Special Collection Procedures Tab 6 Dermal Puncture Tab 7 Point of Care Testing (POCT) Tab 8 Laboratory Tests
£43.71
F.A. Davis Company Clinical Immunology Serology
Book SynopsisIncludes coverage of external defenses and inflammation, human microbe relationships, bacterial virulence factors, the role of B and T cells in the adaptive immune response, the immune mechanisms involved in humoral antibody production and cell-mediated immunity, tumor markers, and immune mechanisms.Table of Contents I. Nature of the Immune System 1. Introduction to Immunity and the Immune System 2. Nature of Antigens and the Major Histocompatibility Complex 3. Innate Immunity 4. Adaptive Immunity 5. Antibody Structure and Function 6. . Cytokines 7. Complement System II. Basic Immunological Procedures 8. Safety and Quality Assessment 9. Principles of Serological Testing 10. Precipitation and Agglutination Reactions 11. Immunoassays 12. Molecular Diagnostic Techniques 13. Flow Cytometry and Laboratory Automation III. Immune Disorders 14. Hypersensitivity 15. Autoimmunity 16. Transplantation Immunology 17. Tumor Immunology 18. Immunoproliferative Diseases 19. Immunodeficiency Diseases IV. Serological and Molecular Diagnosis of Infectious Disease 20. Serological and Molecular Detection of Bacterial Infections 21. Spirochete Diseases 22. Serological and Molecular Diagnosis of Parasitic and Fungal Infections 23. Serology and Molecular Detection of Viral Infections 24. Laboratory Diagnosis of HIV Infection 25. Immunization and Vaccines Glossary Answer Key References Index
£78.30
Wiley Parasites of Lab Animals 2e
Book SynopsisPrepared under the auspices of the American College of Laboratory Animal Medicine, this second edition has been thoroughly updated and revised to improve utility and readability. The book is now organized by vertebrate host species, with parasites presented phylogenetically within chapters. Additional highlights of this edition include introductory chapters on modern diagnostic techniques and parasite biology, and a new appendix features a complete drug formulary. The well-presented and extensively illustrated volume addresses all aspects of laboratory animal parasites. Regarded as the most comprehensive and authoritative work available on the topic, this book is an essential reference for veterinary parasitologists, clinicians, students and laboratory animal scientists.Trade Review“Wait no more! After 35 years, the second edition of Flynn's Parasites of Laboratory Animals has finally arrived.... If you are looking for a well organized reference on parasites found in the research environment, then look no further. This is the most comprehensive, detailed, easy to use compilation available on the market. To collect the equivalent breadth, one would have to purchase many species-specific texts.... A detailed reference to be used to confirm preliminary results and enhance understanding of the impact of discovered infections. The articles are well written in an easy to read, direct, and succinct style... I recommend this text as a practical, user friendly yet extremely comprehensive reference book.” Interface: Newsletter of the Canadian Association for Laboratory Animal Medicine "The similarity of organization of each host chapter makes it easy to develop a method to use this large text. The tables at the end of each host chapter present information based on the host organ system and help direct the reader to more detailed references for each parasite. The text was carefully edited to maintain the same style throughout the book by different contributors.... Although this is not a book to use as a quick guide or a clinical differential, it is a good investment as a comprehensive reference text if: 1) you have an interest in parasitology, especially of laboratory animal species; 2) you are dealing with a commercial operation, such as a producer or distributor of any of these species; 3) you are a practitioner who sees these species on a fairly regular basis as pets." Exotic DVM Magazine “This is a well written and very useful book for those in the field of lab animal medicine. The second edition contains much newer useful information.” Doody’s Book Reviews "This is a well written and very useful book for those in the field of lab animal medicine. This second edition contains much newer useful information." (Allan John Paul, DVM, MS, @Doody's Review Service)Table of ContentsPreface to the Second Edition. List of Contributors. Acknowledgements. Dedication. Chapter 1- Collection, Preservation, and Diagnostic Methods. Chapter 2- Biology of the Protozoa. Chapter 3- Biology of Trematodes and Leeches. Chapter 4- Biology of Cestodes. Chapter 5- Biology of Nematodes and Acanthocephalans. Chapter 6- Biology of Arthropods. Chapter 7- Parasites of Fish. Chapter 8- Parasites of Amphibians. Chapter 9- Parasites of Reptiles. Chapter 10- Parasites of Birds. Chapter 11- Parasites of Rats and Mice. Chapter 12- Parasites of Hamsters. Chapter 13- Parasites of Gerbils. Chapter 14- Parasites of Guinea Pigs. Chapter 15- Parasites of Rabbits. Chapter 16- Parasites of Ferrets. Chapter 17- Parasites of Dogs. Chapter 18- Parasites of Cats. Chapter 19- Parasites of Swine. Chapter 20- Parasites of Sheep and Goats. Chapter 21- Parasites of Non-human Primates. Appendix- Formulary. Glossary
£155.66
Taylor & Francis Inc Sterile Product Facility Design and Project
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
£285.00
Taylor & Francis Inc Disinfection and Decontamination Principles
Book SynopsisIn the battle between humans and microbes, knowledge may be not only the best weapon but also the best defense. Pulling contributions from 34 experts into a unified presentation, Disinfection and Decontamination: Principles, Applications, and Related Issues provides coverage that is both sophisticated and practical. The book reviews the fundamentals, explores the interdisciplinary nature of the science, and includes discussions of regulatory and legal issues. While the chapters present in depth coverage of infections in hospitals, they also widen their scope to include laboratories outside the healthcare environment. Based on practical experience, the volume examines recent advances in the research, development, and applications for disinfection and decontamination in many different settings. The chapters address, and supply insight into, the issues found with infectious disease, devices and new materials for implantation, principles, mechanisms, testing methods and strategieTrade Review"The title is attractive and stimulating, and review of the topics that it implies is timely . . . this book contains material of interest to many microbiologists, and may be recommended for library purchase." – Niall Logan, Glasgow Caledonian University, in Society for General Microbiology, Feb 2009Table of ContentsPerspectives on Infection Challenges and Solutions. Sisyphus in the Microbial World Revisited: Global Governance, Antimicrobial Strategies, and Humanity’s Health. The Need for Safer and Better Microbicides for Infection Control. Microbiological Concerns in Non-Sterile Manufacturing. New Technologies in Disinfection and Infection Control. Biocides: Modes of Action and Mechanisms of Resistance. A Pragmatic Approach to Judicious Selection and Proper Use of Disinfectant and Antiseptic Agents in Healthcare Settings. Extended Activity of Health Care Antiseptic Products. Disinfectant Rotation in a Cleaning Disinfection Program for Clean Rooms and Controlled Environments. Reprocessing Flexible Endoscopes: Origin of Standards, Overview of Structure Function, and Review of Recent Outbreaks. Microbiological Testing of Disinfectants and Decontaminants for Critical Surfaces. Regulatory Constraints on Disinfectants and Decontamination. Biofilms: A Summarized Account and Control Strategies. Consequences of Biofilms on Indwelling Medical Devices: Costs and Prevention. Infection-Resistant Implantable Devices: Biofilm Problems and Design Strategies. Infections of Intracardiac Devices. Intrauterine Devices: Infections and Biofilms. Antimicrobial Urinary Catheters. Risk Factors for Postoperative Infectious Complications after Abdominal Surgery. Index. Authors.
£175.75
Royal Society of Chemistry Alternatives To Animal Testing
Book SynopsisAnimal experimentation has long been a controversial issue with impassioned arguments on both sides of the debate. Increasingly it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics include; the safety evaluation of chemicals, international validation and barriers to the validation of alternative tests, in vitro testing for endocrine disruptors, intelligent approaches to safety evaluation of chemicals, alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate studeTrade ReviewA state-of-the-art description of the evaluation of the safety of chemicals, difficulties with internationally accepted validation, barriers to the acceptance of nonanimal tests, and possible future directions.Important reading for all involved with pharmaceuticals and cosmetics. * Journal of Medicinal Chemistry, 2007, Vol.50.No.8 (Carl Kaiser) *Table of ContentsPart One: General Overview of the Safety Evaluation of Chemicals; 1: Introduction; 2: Legislation and regulatory requirements; 3: The regulatory paradigm; 4: The interface between toxicology and risk assessment; 5: Interpreting toxicology; 6: Conclusions; 7: References; Part Two: International Validation and Barriers to the Validation of Alternative Tests; 1: Introduction; 2: Background to the Validation Process; 3: The Validation Process; 4: Problems Being Encountered in Implementing the Validation Process; 5: The Need for an Invalidation Process; 6: Concluding Remarks; 7: References; Part Three: In Vitro Testing for Endocrine Disruptors; 1: Introduction; 2: In Silico Approaches; 3: In Vitro Tests for EDs; 4: Discussion; 5: Conclusions; 6: Acknowledgement; 7: References; Part Four: Intelligent Approaches to Safety Evaluation; 1: Introduction; 2: Hazardous properties assessment; 3: Risk Assessment; 4: Existing Studies and Literature Data; 5: Surrogate Data: Calculation, Read Across and SAR/QSAR; 6: Alternatives to Animal Toxicology Studies; 7: Data Waivers; 8: Expert reports and weight of evidence; 9: Preliminary risk assessments; 10: EU Registration, Evaluation and Registration scheme (REACH); 11: Data for REACH; 12: Regulatory planning & liaison with the regulators; 13: Common themes; 14: Acknowledgements; 15: References; Part Five: Alternative Tests and the 7th Amendment to the Cosmetics Directive; 1: Introduction; 2: Overview of current approaches to risk assessment for cosmetics; 3: 7th amendment to the EU Cosmetics Directive (76/768/EEC); 4: Status of alternative tests; 5: Endpoints where risk assessment for cosmetics can be achieved without using animal data; 6: Endpoints where risk assessment for cosmetics cannot currently be achieved without using animal data; 7: New approaches to risk assessment without animals; 8: Acknowledgements; 9: References;
£56.95
ASCP Press Quick Compendium of Medical Laboratory Sciences
Book SynopsisThe new Quick Compendium of Medical Laboratory Sciences (or QCMLS) is the latest tool that ASCP is offering to students preparing for the ASCP Board of Certification (BOC) Medical Laboratory Scientist (MLS) and Medical Laboratory Technician (MLT) certification examinations.
£91.80
Cambridge University Press Manual of Intracytoplasmic Sperm Injection in
Book SynopsisFor around half of the couples who have trouble conceiving the cause of infertility is sperm-related. Intracytoplasmic sperm injection (ICSI) is the most common and successful treatment for male infertility. Here, the pioneers for the technique, along with authorities in the field, describe the underlying science of ICSI and other micromanipulation techniques. Practical advice for performing the techniques is covered in depth, including sperm selection, laser-assisted ICSI, and the use of piezo in ICSI. Examining the safety of ICSI in animal models as well as the impact of ICSI on the health and well-being of the children conceived through the procedure is discussed. This manual is an essential resource for clinical embryologists and laboratory personnel wishing to refine or develop techniques and improve outcomes.Table of ContentsForeword Zev Rosenwaks; 1. In-vitro fertilization and micromanipulation: The history that changed the treatment of male factor infertility Jacques Cohen; 2. Development of ICSI in human assisted reproduction Stephanie Cheung, Alessandra Parrella, Philip Xie, Sherina Lawrence, Mounia Haddad, Derek Keating, Zev Rosenwaks and Gianpiero D. Palermo; 3. Current ICSI applications and clinical outcomes Derek Keating, Stephanie Cheung, Philip Xie, June Wang, Zev Rosenwaks and Gianpiero D. Palermo; 4. Rescue ICSI of IVF failed-fertilized oocytes Carly Barber, Vivian Nguyen, Alexandrea Ramsey and Zsolt Peter Nagy; 5. High-magnification sperm selection before ICSI Pierre Vanderzwalmen, Barbara Wirleitner, Guy Cassuto, Romain Imbert and Maximillian Murtinger; 6. Laser-assisted ICSI Roberta Maggiulli, Simona Alfano, Erminia Alviggi, Gemma Fabozzi, Danilo Cimadomo, Filippo Maria Ubaldi and Laura Rienzi; 7. Piezo: The add-on to standardize ICSI procedure Tetsunori Mukaida, Kenichiro Hiraoka, Hideaki Watanabe, Kiyotaka Kawai and Csaba Pribenszky; 8. Artificial oocyte activation after ICSI Thomas Ebner; 9. Health of children born after Intracytoplasmic Sperm Injections (ICSI) Shahad Sabti and Alastair G. Sutcliffe; 10. Examining the safety of Intracytoplasmic Sperm Injection (ICSI) using animal models Laura Hewitson; 11. Cellular and molecular events after ICSI in clinically relevant animal models Lauren Hamilton, Richard J. Oko and Peter Sutovsky; 12. Micromanipulation, microinjection microscopes and systems for ICSI Steven D. Fleming; 13. Automation techniques and systems for ICSI Changsheng Dai, Zhuoran Zhang, Guanqiao Shan and Yu Sun; 14. Germline nuclear transfer technology to overcome mitochondrial diseases and female infertility Mao-Xing Tang, Annekatrien Boel, Paul Couke and Björn Heindryckx; 15. Nuclear transfer technology and its use in reproductive medicine Pasqualino Loi, Marta Czernik, Luca Palazzese, Pier Augusto Scapolo, Helena Fulka and Josef Fulka Jr; 16. The prospects of infertility treatment using 'artificial' eggs Katsuhiko Hayashi; Index.
£39.89
Cambridge University Press Manual of Embryo Culture in Human Assisted
Book SynopsisWhilst assisted reproduction techniques (ART) have become increasingly successful and largely standardized, there is still only a partial understanding of what constitutes a ''true'' embryo environment. Replicating the varying physiological conditions of the in-vivo environment that the embryo travels through in the in-vitro culture is still a major challenge in ART. This practical volume details how to organize and operate an IVF laboratory in order to mimic these conditions for successful embryo culture. Environments and equipment that are essential for running safe and efficient facilities such as maintaining good air quality and hygiene protocols, and utilizing an effective layout are covered in detail. Other chapters discuss the different consumables needed, optimal handling techniques and parameter monitoring systems, as well as recent advances in the area including artificial intelligence and automation. This is an indispensable guide to understanding the background science of cTrade Review'This book is a highly readable, excellent resource for anyone interested in IVF or embryo culture.' Karla Saner Amigh, Doody's Review ServiceTable of ContentsIntroduction to Embryo Culture Kersti Lundin and Aisling Ahlstrom; 1. Facilities for Embryo Culture Julius Hreinsson; 2. Incubators for Embryo Culture Borut Kovacic; 3. Consumables for the IVF laboratory – Production and Validation, Quality Control and Bioassays Hubert Joris; 4. Embryo Metabolism and what does the Embryo Need? – Embryo Stress Paula Vergaro and Roger G. Sturmey; 5. Culture Media and Embryo Culture Arne Sunde and Roger G. Sturmey; 6. Optimal Handling Techniques for Embryo Culture Michael Reed and Thomas Pool; 7. From Identification to Witnessing – Traceability to Ensure the Safety of the Embryo During Culture Kelly Tilleman and Annelies Tolpe; 8. Timing of Embryo Culture Ioannis Sfontouris; 9. Time-lapse Microscopy for Embryo Culture Kirstine Kirkegaard and Thomas Freour; 10. Laboratory Monitoring for Embryo Culture Carlotta Zaca, Andrea Borini, and Giovanni Coticchio; 11. Embryo Culture and IVF Offspring Outcome John C. Dumoulin and Aafke van Montfoort; 12. The Changing Culture of Embryo Culture – Advances in the IVF Culture System Carole Curchoe and Jason E. Swain.
£39.89
John Wiley & Sons Inc Dried Blood Spots
Book SynopsisAn informative and comprehensive book on the applications and techniques of dried blood spot sampling Dried blood spot (DBS) sampling involves the collection of a small volume of blood, via a simple prick or other means, from a study subject onto a cellulose or polymer paper card, which is followed by drying and transfer to the laboratory for analysis. For many years, this method of blood sample collection has been extensively utilized in some important areas of human healthcare (for example, newborn screening for inherited metabolic disorders and HIV-related epidemiological studies). Because of its advantages over conventional blood, plasma, or serum sample collection, DBS sampling has been valued by the pharmaceutical industry in drug research and development. Dried Blood Spots: Applications and Techniques features contributions from an international team of leading scientists in the field. Their contributions present a unique resource on the history, pTable of ContentsPREFACE viii CONTRIBUTORS x PART I HISTORY, APPLICATIONS, AND HEALTHCARE 1 Overview of the History and Applications of Dried Blood Samples 3 W. Harry Hannon and Bradford L. Therrell, Jr. 2 Dried Blood Spot Cards 16 Brad Davin and W. Harry Hannon 3 Dried Blood Spot Sample Collection, Storage, and Transportation 21 Joanne Mei 4 Dried Blood Spot Specimens for Polymerase Chain Reaction in Molecular Diagnostics and Public Health Surveillance 32 Chunfu Yang 5 Application of Enzyme Immunoassay Methods Using Dried Blood Spot Specimens 40 Mireille B. Kalou 6 Applications of Dried Blood Spots in Newborn and Metabolic Screening 53 Donald H. Chace, Alan R. Spitzer, and Víctor R. De Jesús 7 Dried Blood Spots for Use in HIV-Related Epidemiological Studies in Resource-Limited Settings 76 Sridhar V. Basavaraju and John P. Pitman 8 Use of Dried Blood Spot Samples in HCV-, HBV-, and Influenza-Related Epidemiological Studies 95 Harleen Gakhar and Mark Holodniy 9 Applications of Dried Blood Spots in General Human Health Studies 114 Eleanor Brindle, Kathleen A. O’Connor, and Dean A. Garrett 10 Applications of Dried Blood Spots in Environmental Population Studies 130 Antonia M. Calafat and Kayoko Kato 11 The Use of Dried Blood Spots and Stains in Forensic Science 140 Donald H. Chace and Nicholas T. Lappas PART II PHARMACEUTICAL APPLICATIONS 12 Pharmaceutical Perspectives of Use of Dried Blood Spots 153 Christopher Evans and Neil Spooner 13 Punching and Extraction Techniques for Dried Blood Spot Sample Analysis 160 Philip Wong and Christopher A. James 14 Considerations in Development and Validation of LC-MS/MS Method for Quantitative Analysis of Small Molecules in Dried Blood Spot Samples 168 Wenkui Li 15 Challenges and Experiences with Dried Blood Spot Technology for Method Development and Validation 179 Chester L. Bowen and Christopher A. Evans 16 Clinical Implications of Dried Blood Spot Assays for Biotherapeutics 188 Matthew E. Szapacs and Jonathan R. Kehler 17 Potential Role for Dried Blood Spot Sampling and Bioanalysis in Preclinical Studies 195 Qin C. Ji and Laura Patrone 18 Clinical and Bioanalytical Evaluation of Dried Blood Spot Sampling for Genotyping and Phenotyping of Cytochrome p450 Enzymes in Healthy Volunteers 202 Theo de Boer, Izaak den Daas, Jaap Wieling, Johan Wemer, and LingSing Chen 19 Application of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring 216 Kenneth Kulmatycki, Wenkui Li, Xiaoying (Lucy) Xu, and Venkateswar Jarugula 20 Automation in Dried Blood Spot Sample Collection, Processing, and Analysis for Quantitative Bioanalysis in Pharmaceutical Industry 229 Leimin Fan, Katty Wan, Olga Kavetskaia, and Huaiqin Wu 21 Beyond Dried Blood Spots—Application of Dried Matrix Spots 235 Shane R. Needham PART III NEW TECHNOLOGIES AND EMERGING APPLICATIONS 22 Direct Analysis of Dried Blood Spot Samples 245 Paul Abu-Rabie 23 Paper Spray Ionization for Direct Analysis of Dried Blood Spots 298 Jiangjiang Liu, Nicholas E. Manicke, R. Graham Cooks, and Zheng Ouyang 24 Direct Solvent Extraction and Analysis of Biomarkers in Dried Blood Spots Using a Flow-Through Autosampler 314 David S. Millington, Haoyue Zhang, M. Arthur Moseley, J. Will Thompson, and Peter Smith 25 Development of Biomarker Assays for Clinical Diagnostics Using a Digital Microfluidics Platform 325 David S. Millington, Ramakrishna Sista, Deeksha Bali, Allen E. Eckhardt, and Vamsee Pamula 26 Applications and Chemistry of Cellulose Papers for Dried Blood Spots 332 Jacquelynn Luckwell, Åke Danielsson, Barry Johnson, Sarah Clegg, Mark Green, and Alan Pierce 27 Derivatization Techniques in Dried Blood Spot Analysis 344 Ann-Sofie M.E. Ingels, Nele Sadones, Pieter M.M. De Kesel, Willy E. Lambert, and Christophe P. Stove INDEX 355
£100.76
Taylor & Francis Ltd Introduction to Software for Chemical Engineers
Book SynopsisThe field of Chemical Engineering and its link to computer science is in constant evolution and new engineers have a variety of tools at their disposal to tackle their everyday problems. Introduction to Software for Chemical Engineers, Second Edition provides a quick guide to the use of various computer packages for chemical engineering applications. It covers a range of software applications from Excel and general mathematical packages such as MATLAB and MathCAD to process simulators, CHEMCAD and ASPEN, equation-based modeling languages, gProms, optimization software such as GAMS and AIMS, and specialized software like CFD or DEM codes. The different packages are introduced and applied to solve typical problems in fluid mechanics, heat and mass transfer, mass and energy balances, unit operations, reactor engineering, process and equipment design and control. This new edition offers a wider view of packages including open source software such as R, Python and JuTable of ContentsSection 1. Modeling and Simulation in the Chemical Eng CV and Its Application to Industry. Chapter 1. Modeling, Simulation and Optimization in the Chemical Engineering Curriculum. Chapter 2. Mathematical Modeling and Simulation. Section 2. General Tools. Chapter 3. Excel. Chapter 4. MATLAB. Chapter 5. Mathematica/Mathcad. Chapter 6. Python. Chapter 7. R. Statistics and Data Management. Section 3. Detailed Equipment Design and Analysis. Chapter 8. Transport Phenomena Analysis (CFD). Chapter 9. Discrete Element Methods. Section 4. Process Simulation. Chapter 10. Equation-Based Process Simulation gProms, EMSO. Chapter 11. Engineering Equation Solver. Chapter 12. Modular Process Simulation ASPEN HYSYS1; CHEMCAD2; ASPEN Plus). Section 5. Process Design and Optimization. Chapter 13. Algebraic Modeling and Optimization. Introduction to GAMS, AIMS, AMPLE, MILP, NLP, MINLP Models. Chapter 14. Production Processes. Chapter 15. Scheduling. Chapter 16 . Plant Location: Supply Chain. Chapter 17. Dynamics Optimization. Chapter 18. Julia for Process Design and Optimization
£82.64
John Wiley & Sons Invasive Cardiology A Manual for Cath Lab
Book Synopsis
£81.00
John Wiley & Sons Clinical Hematology Theory Procedures Enhanc
Book Synopsis
£104.40
Springer Us Gene Mapping in Laboratory Mammals Part A
Book SynopsisThe present work is an attempt to provide a systematic treatment of genetic linkage in diploid heredity. A large proportion, if not the majority, of mutant genes fail to match up to 'textbook' genes-with faultless segregation ratios and expression-yet, these are the materials with which the practical researcher has to cope.Table of Contentsof Part A.- A: The Biometrical Approach.- 1 Introduction.- 2 Maximum Likelihood Estimation.- 3 Inviability, Impenetrance and Linkage Detection.- 4 Estimation with Normal Gene Ratios.- 5 Estimation with Inviability.- 6 Estimation with Impenetrance.- 7 Estimation with Inviability and Impenetrance.- 8 Scoring.- 9 Multi-point Crosses.- 10 Mapping Functions.- 11 General Bibliography.- Index of Part A.
£40.49
Authorhouse UK Laboratory Total Quality Management for Practitioners and Students of Medical Laboratory Science
£18.60
Taylor & Francis Inc EU Annex 11 Guide to Computer Validation
Book SynopsisGood Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.The ideas presented in this book are based on the author's 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functiTable of ContentsIntroduction. SLC, Computer Validation, and Annex 11. Annex 11 Principles. Risk Management. Personnel. Suppliers and Service Providers. Validation. Data. Accuracy Checks. Data Storage. Printouts. Audit Trails—Ensuring Data Integrity. Change and Configuration Management. Periodic Evaluation: Independent Review to Ensure Continued Validation of Computerized Systems. Security. Incident Management. Electronic Signatures: Electronic Signing Requirements. Batch Certification and Release. Business Continuity. Archiving. SLC Documentation. Relevant Procedural Controls. Maintaining the Validated State in Computer Systems. Annex 11 and the Cloud. EU GMP Chapter 4–Documentation and Annex 11. Annex 11 and Electronic Records Integrity. Annex 11 and 21 CFR Part 11: Comparisons for International Compliance.
£189.00
CSIRO Publishing A Practical Guide to Global PointofCare Testing
Book SynopsisA practical guide on point-of-care testing for health professionals working in community-based primary care settings.
£90.90
Nova Science Publishers Inc Rattus norvegicus A Review and Directions for
Book Synopsis
£58.39