Generic drug product development : bioequivalence issues / [edited by] Isadore Kanfer, Leon Shargel.
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 de...
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| Online Access: |
Full Text (via Taylor & Francis) |
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| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
New York :
Informa Healthcare,
©2008.
|
| Series: | Drugs and the pharmaceutical sciences ;
180. |
| Subjects: |
Table of 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]