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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Full Text (via Taylor & Francis) |
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| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
New York :
Informa Healthcare,
©2008.
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| Series: | Drugs and the pharmaceutical sciences ;
180. |
| Subjects: |
MARC
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| 245 | 0 | 0 | |a Generic drug product development : |b bioequivalence issues / |c [edited by] Isadore Kanfer, Leon Shargel. |
| 260 | |a New York : |b Informa Healthcare, |c ©2008. | ||
| 300 | |a 1 online resource (x, 264 pages) : |b illustrations. | ||
| 336 | |a text |b txt |2 rdacontent. | ||
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| 490 | 1 | |a Drugs and the pharmaceutical sciences ; |v 180. | |
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 505 | 0 | |a 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. | |
| 505 | 0 | |a 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. | |
| 505 | 0 | |a 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] | |
| 520 | |a 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. | ||
| 588 | 0 | |a Print version record. | |
| 650 | 0 | |a Drugs |x Therapeutic equivalency. |0 http://id.loc.gov/authorities/subjects/sh85039756. | |
| 650 | 0 | |a Drugs |x Bioavailability. |0 http://id.loc.gov/authorities/subjects/sh85039723. | |
| 650 | 0 | |a Generic drugs. |0 http://id.loc.gov/authorities/subjects/sh89000501. | |
| 650 | 7 | |a Drugs |x Bioavailability. |2 fast |0 (OCoLC)fst00898775. | |
| 650 | 7 | |a Drugs |x Therapeutic equivalency. |2 fast |0 (OCoLC)fst00898955. | |
| 650 | 7 | |a Generic drugs. |2 fast |0 (OCoLC)fst00939969. | |
| 700 | 1 | |a Kanfer, Isadore. |0 http://id.loc.gov/authorities/names/no2005011582 |1 http://isni.org/isni/0000000043722020. | |
| 700 | 1 | |a Shargel, Leon, |d 1941- |0 http://id.loc.gov/authorities/names/n79147688 |1 http://isni.org/isni/0000000110046692. | |
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| 830 | 0 | |a Drugs and the pharmaceutical sciences ; |v 180. |0 http://id.loc.gov/authorities/names/n42009973. | |
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