Sample Size Estimation and Passing Rate Analysis for Highly Variable Drugs Using FDA’s Scaled Average Bioequivalence Approach
PRESENTED TO: BioPharma Services Inc.
PRESENTED BY: N. RAYAD, N. GHARAVI, J. HE, F. TRABELSI
PURPOSE
Sample Size Estimation and Passing Rate Analysis for Highly Variable Drugs Using FDA’s Scaled Average Bioequivalence Approach – The sample size estimation required for a bioequivalence (BE) study is driven by the intra-subject coefficient of variation (ISCV), the Geometric mean ratio (GMR) and the target statistical power to meet bioequivalence limits.
For highly variable drugs (HVDs) defined by an ISCV ≥30%, it is difficult to demonstrate BE unless many subjects are enrolled. The US FDA proposes using a reference replicate study design to scale up the acceptance criteria limit considering the reference drug for both Cmax and AUC parameters for HVDs.
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