Generic Drug Product Development: Bioequivalence Issues

✍ Scribed by Isadore Kanfer (ed.), Leon Shargel (ed.)

Publisher: Informa Healthcare
Year: 2008
Tongue: English
Leaves: 278
Series: Drugs and the Pharmaceutical Sciences 180
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

✦ Table of Contents

Content: Introduction--
bioequivalence issues / Isadore Kanfer and Leon Shargel --
Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber --
Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer --
Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel. Bioequivalence using clinical endpoint studies / Christopher Hendy --
Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi --
Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon. Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme --
Role of metabolites in bioequivalence assessent / André Jackson --
Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali. Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer --
Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.].

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