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Generic drug product development : bioequivalence issues

Author: Isadore Kanfer; Leon Shargel
Publisher: New York : Informa Healthcare, ©2008.
Series: Drugs and the pharmaceutical sciences, 180.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Generic drug product development.
New York : Informa Healthcare, ©2008
(DLC) 2007039078
(OCoLC)173469782
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Isadore Kanfer; Leon Shargel
ISBN: 1420020013 9781420020014
OCLC Number: 608629706
Reproduction Notes: Electronic reproduction. [S.l.] : HathiTrust Digital Library, 2010. MiAaHDL
Description: 1 online resource (x, 264 pages) : illustrations.
Details: Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002.
Contents: 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 [and others].
Series Title: Drugs and the pharmaceutical sciences, 180.
Responsibility: [edited by]Isadore Kanfer, Leon Shargel.
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