Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration-Reference-Cited by-同舟云学术

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Published:2012-09-13 Issue:4 Volume:14 Page:915-924
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Davit Barbara M.,Chen Mei-Ling,Conner Dale P.,Haidar Sam H.,Kim Stephanie,Lee Christina H.,Lionberger Robert A.,Makhlouf Fairouz T.,Nwakama Patrick E.,Patel Devvrat T.,Schuirmann Donald J.,Yu Lawrence X.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-012-9406-x.pdf

Reference58 articles.

1. Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter A, Drugs and Devices Section 355(j)(8)(B)(i).

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3. Westlake WJ. Bioequivalence testing: a need to rethink. Biometrics. 1981;37:589–94.

4. Blume HH, Midha KK. Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci. 1993;82:1186–9.

5. Shah VP, Yacobi A, Barr WH, Benet LZ, Breimer D, et al. Evaluation of orally administered highly variable drugs and drug formulations. Pharm Res. 1996;13:1590–4.

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