Bio-equivalence Assessment

Bioequivalence Assessment studies are used to compare the expected in vivo biological equivalence of two formulations of a drug and this study is to assure therapeutic equivalence of generic products to innovator products. In the bioequivalence study, bioavailability should be compared for innovator and generic products. If this is not feasible, pharmacological effects supporting therapeutic efficacy or therapeutic effectiveness in major indications should be compared (These comparative tests are hereafter called pharmacodynamics studies and clinical studies, respectively). For oral products, dissolution tests should be performed, since they provide important information concerning bioequivalence.

Bioequivalence assessment includes strategies of topical dosage forms and bio equivalence approaches for transdermal dosage form and assessment of respiratory dosage form.

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