Unit 15: Bioequivalence (including S & S² calculations)
Bioequivalence ensures that generic drugs match innovator products in absorption rate and extent, assessed through pharmacokinetic parameters and statistical analysis. Regulatory acceptance requires 90% confidence intervals for Cmax and AUC within 80–125%.
Definition
Bioequivalence refers to the absence of a significant difference in the rate and extent of absorption of two pharmaceutical products when administered at the same molar dose under similar conditions.
It ensures that generic products perform similarly to innovator products in terms of safety and efficacy. Regulatory agencies require bioequivalence studies for generic drug approval.
Key Points
FDA and EMA guidelines govern bioequivalence studies
Measured using pharmacokinetic parameters like Cmax, Tmax, and AUC
Statistical analysis includes confidence intervals and variance calculations
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