Bioequivalence Requirements in Various Global Jurisdictions, Isadore Kanfer

Автор: Isadore Kanfer
Название: Bioequivalence Requirements in Various Global Jurisdictions
ISBN: 3319680773 ISBN-13(EAN): 9783319680774
Издательство: Springer
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Цена: 25155.00 р.
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Описание:

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the

Автор: Lawrence X. Yu; Bing V. Li
Название: FDA Bioequivalence Standards
ISBN: 1493912518 ISBN-13(EAN): 9781493912513
Издательство: Springer
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Цена: 25155.00 р.
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Автор: Lawrence X. Yu; Bing V. Li
Название: FDA Bioequivalence Standards
ISBN: 1493955586 ISBN-13(EAN): 9781493955589
Издательство: Springer
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Цена: 19564.00 р.
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Описание:

.- 1 Bioequivalence History

.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu

.- 2 Fundamentals of Bioequivalence

.- Mei-Ling Chen

.- 3 Basic Statistical Considerations

.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann

.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence

.- Wayne I. DeHaven and Dale P. Conner

.- 5 Biowaiver and Biopharmaceutics Classification System

.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu

.- 6 Bioequivalence of Highly Variable Drugs

.- Barbara M. Davit and Devvrat T. Patel

.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments

.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu

.- 8 Bioequivalence for Narrow Therapeutic Index Drugs

.- Wenlei Jiang and Lawrence X. Yu

.- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies

.- Peng Zou and Lawrence X. Yu

.- 10 Clinical Endpoint Bioequivalence Study

.- John R Peters