Design And Analysis Of Bioavailability And Bioequivalence Studies
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Design And Analysis Of Bioavailability And Bioequivalence Studies
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 1999-11-24
Design And Analysis Of Bioavailability And Bioequivalence Studies written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-11-24 with Mathematics categories.
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
Design And Analysis Of Bioavailability And Bioequivalence Studies
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2008-10-15
Design And Analysis Of Bioavailability And Bioequivalence Studies written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-15 with Mathematics categories.
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
Generics And Bioequivalence
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Author : Andre J. Jackson
language : en
Publisher: CRC Press
Release Date : 1994-06-23
Generics And Bioequivalence written by Andre J. Jackson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-06-23 with Medical categories.
Generics and Bioequivalence provides a clear, insightful, and in-depth analysis of the many complex issues encountered in the determination of drug bioequivalence. Included are timely updates on many controversial and newly emerging areas in the design and analysis of bioavailability and bioequivalence studies. This new reference was prepared by a group of authorities from academe, industry, and government and can be easily understood by students and experienced scientists alike. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence, stereochemical considerations in bioequivalence evaluation, uses of animal models, pharmacodynamics, and statistics. The analysis of pharmacodynamic data (especially when plasma levels are unavailable) is covered, and the nascent importance of individual bioequivalence is examined.
Topical Drug Bioavailability Bioequivalence And Penetration
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Author : Vinod P. Shah
language : en
Publisher: Springer Science & Business Media
Release Date : 1993-11-30
Topical Drug Bioavailability Bioequivalence And Penetration written by Vinod P. Shah and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-11-30 with Medical categories.
This volume presents the state-of-the-art of measuring percutaneous penetration and determining biological relevance in dermal and transdermal drug delivery. Both in vivo and in vitro models and methods are discussed in detail to provide pharmaceutical drug developers with an invaluable guide and reference.
Pharmaceutical Medicine
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Author : Adrian Kilcoyne
language : en
Publisher: OUP Oxford
Release Date : 2013-05-23
Pharmaceutical Medicine written by Adrian Kilcoyne and has been published by OUP Oxford this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-23 with Medical categories.
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Oral Drug Absorption
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Author : Jennifer B. Dressman
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Oral Drug Absorption written by Jennifer B. Dressman and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
Handbook Of Bioequivalence Testing
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2007-08-22
Handbook Of Bioequivalence Testing written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-08-22 with Medical categories.
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
Sample Size Calculations In Clinical Research
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2003-03-04
Sample Size Calculations In Clinical Research written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-04 with Mathematics categories.
Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Bioequivalence And Statistics In Clinical Pharmacology
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Author : Scott D. Patterson
language : en
Publisher: CRC Press
Release Date : 2017-03-27
Bioequivalence And Statistics In Clinical Pharmacology written by Scott D. Patterson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-27 with Mathematics categories.
Maintaining 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 designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.