Question

Define Bioavailability and Bioequivalence and explain study designs for conducting bioequivalence study. (Biopharmaceutics And Pharmacokinetics)

Answer 1

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A typical process for bioequivalence assessment is to conduct a bioequivalence study with male healthy volunteers under the assumption that bioequivalence (relative bioavailability) of the drug product under investigation is predictive of clinical outcomes (i.e., safety and efficacy) of the drug product in clinical .