volume 21, issue 13, P1825-1847 2002
DOI: 10.1002/sim.1151
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Abstract: Bioequivalence studies are conducted to demonstrate equivalence in the bioavailability of the active ingredient in different formulations. The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies to show bioequivalence between generic drugs and brand drugs before approval. A recent FDA guidance on bioequivalence proposes criteria for assessment of population bioequivalence (PBE) and individual bioequivalence (IBE) i…

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