Why Dissolution Testing Alone Is Not Sufficient for Generic Drug Approval: Bioequivalence Studies in Ensuring Therapeutic Equivalence

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An educational infographic comparing In-Vitro Dissolution Testing in a laboratory to In-Vivo Bioequivalence Studies in humans for generic drug approval. The left side shows lab apparatus (beakers, dissolution tester) measuring drug release. An arrow transitions to the right side, which depicts a human circulatory system, blood sample, and a pharmacokinetic graph measuring bioavailability. The bottom center outlines why dissolution alone is insufficient, highlighting BCS Class II & IV drugs and major regulatory bodies like USFDA, EMA, TGA, and Health Canada.

Generic medicines play a vital role in improving access to affordable healthcare worldwide. Compared with innovator or reference products, generic […]

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