Understanding the Scientific Issues Embedded in the Generic Drug Approval Process-Reference-Cited by-同舟云学术

Understanding the Scientific Issues Embedded in the Generic Drug Approval Process

Published:2001-11 Issue:6 Volume:41 Page:856-867
ISSN:1086-5802
Container-title:Journal of the American Pharmaceutical Association (1996)
language:en
Short-container-title:Journal of the American Pharmaceutical Association (1996)

Author:

Welage Lynda S.,Kirking Duane M.,Ascione Frank J.,Gaither Caroline A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference65 articles.

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3. Generic drugs. Therapeutic equivalence;Meredith;Drug Saf.,1996

4. Bioequivalence. An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products;Marzo;Arzneimittelforschung.,1995

5. Bioavailability and Bioequivalence Requirements, 21 CFR § 320.1-63 (2001).

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