Generic Drug Product Development: Bioequivalence Issues

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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 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 ...

Generic Drug Product Development: Bioequivalence Issues 2007, Informa Medical, New York, NY

ISBN-13: 9780849377846

Hardcover

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