Sample size, ANOVA, GMR, RSABE, NTI, and regulatory pathway analysis
Calculate required subjects for bioequivalence studies with power analysis
Determine optimal sample size for pharmacokinetic studies
Calculate required washout period based on drug half-life for crossover studies
Compare crossover and parallel study designs for clinical PK trials
Compute 2x2 crossover ANOVA decomposition for BE studies with F-tests, p-values, intra-subject CV%, and MSE
Calculate 90% CI for bioequivalence from summary statistics (GMR, CV%, N) using TOST procedure
Calculate geometric mean ratio and 90% confidence interval for bioequivalence against 80-125% limits
Calculate reference-scaled average bioequivalence for highly variable drugs with Swr threshold and scaled limits
Calculate bioequivalence for narrow therapeutic index drugs with tightened 90-111% limits
Explore how sample size and intra-subject CV% affect statistical power for bioequivalence studies
Determine optimal regulatory pathway: ANDA, 505(b)(2), or product-specific with biowaiver eligibility