Understanding the 90% Confidence Interval Rule in Bioequivalence Studies
Understanding the 90% Confidence Interval Rule in Bioequivalence Studies How the 90% Confidence Interval Rule Shapes Bioequivalence Decisions Introduction: The Role of Statistics in Bioequivalence In bioavailability and bioequivalence (BA/BE) studies, demonstrating therapeutic equivalence between a generic and a reference drug is a regulatory cornerstone. Among various statistical tools, the 90% confidence interval (CI) rule…
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