| Description |
1 online resource (x, 264 pages) : illustrations |
| Series |
Drugs and the pharmaceutical sciences ; 180 |
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Drugs and the pharmaceutical sciences ; 180.
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| 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 |
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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 |
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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 |
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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] |
| 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 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 consid |
| Bibliography |
Includes bibliographical references and index |
| Notes |
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. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL |
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Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force. WlAbNL |
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digitized 2010 HathiTrust Digital Library committed to preserve pda MiAaHDL |
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Print version record |
| Subject |
Drugs -- Therapeutic equivalency.
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Drugs -- Bioavailability.
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Generic drugs.
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Bioavailability.
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Drugs, Generic
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Biological Availability
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Therapeutic Equivalency
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MEDICAL -- Pharmacology.
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Bioavailability.
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Drugs -- Bioavailability.
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Drugs -- Therapeutic equivalency.
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Generic drugs.
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| Form |
Electronic book
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| Author |
Kanfer, Isadore.
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Shargel, Leon, 1941-
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| ISBN |
1420020013 |
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9781420020014 |
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9780429132902 |
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0429132905 |
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