Developing and Demonstrating Bioequivalence of Semi-Solid Dosage Forms

The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing as a surrogate for in vivo testing. In this paper, we explain how bioequivalence can be achieved for generics in semi-solid dosage forms, including the role of in vitro release testing (IVRT) and in vitro permeation testing (IVPT).

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