Generic Drug Product Development

Bioequivalence Issues

By: Isadore Kanfer, Leon Shargel

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eText | 15 November 2007 | Edition Number 1

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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 comp