Design and Analysis of Bioavailability and Bioequivalence Studies
Title | Design and Analysis of Bioavailability and Bioequivalence Studies PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 758 |
Release | 2008-10-15 |
Genre | Mathematics |
ISBN | 1420011677 |
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
Design and Analysis of Bioavailability and Bioequivalence Studies
Title | Design and Analysis of Bioavailability and Bioequivalence Studies PDF eBook |
Author | Shein-Chung Chow |
Publisher | CRC Press |
Pages | 606 |
Release | 1999-11-24 |
Genre | Mathematics |
ISBN | 9781420002027 |
"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, Second Edition, Revised and Expanded, by Shein-Chung Chow and Jen-Pei Liu
Title | Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition, Revised and Expanded, by Shein-Chung Chow and Jen-Pei Liu PDF eBook |
Author | Robert Schall |
Publisher | |
Pages | 5 |
Release | 2018 |
Genre | |
ISBN |
Bioequivalence Studies in Drug Development
Title | Bioequivalence Studies in Drug Development PDF eBook |
Author | Dieter Hauschke |
Publisher | John Wiley & Sons |
Pages | 328 |
Release | 2007-03-13 |
Genre | Medical |
ISBN | 0470094761 |
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.
Generics and Bioequivalence
Title | Generics and Bioequivalence PDF eBook |
Author | Andre J. Jackson |
Publisher | CRC Press |
Pages | 309 |
Release | 2019-06-13 |
Genre | Medical |
ISBN | 0429558678 |
Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.
Conduct and Analysis of Bioavailability and Bioequivalence Studies
Title | Conduct and Analysis of Bioavailability and Bioequivalence Studies PDF eBook |
Author | Canada. Health Canada |
Publisher | |
Pages | 134 |
Release | 1996 |
Genre | Bioavailability |
ISBN | 9780662252351 |
FDA Bioequivalence Standards
Title | FDA Bioequivalence Standards PDF eBook |
Author | Lawrence X. Yu |
Publisher | Springer |
Pages | 472 |
Release | 2014-09-05 |
Genre | Medical |
ISBN | 1493912526 |
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.