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J Psychosoc Nurs Ment Health Serv. 2009 Dec;47(12):17-20. doi: 10.3928/02793695-20091103-99.

What makes a generic medication generic?

Author information

1
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA 15213, USA. HowlandRH@upmc.edu

Abstract

By law, the U.S. Food and Drug Administration (FDA) can approve generic versions of brand-name drugs without requiring that research be conducted to prove them safe and effective. However, compared with a brand-name drug, a generic drug must demonstrate that it (a) contains the same active ingredients; (b) is identical in strength, dosage form, and route of administration; (c) is bioequivalent; (d) has the same clinical use indications; (e) meets the same batch requirements for identity, strength, purity, and quality; and (f) is manufactured according to the same FDA regulations. The most important aspect of generic drug development are the concepts of bioavailability and bioequivalence. According to the concept of bioequivalence, if a drug product contains an active ingredient that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is considered to be clinically equivalent and can be substituted for that drug product.

PMID:
20000278
DOI:
10.3928/02793695-20091103-99
[Indexed for MEDLINE]

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