Bioequivalence and Bioavailability Forum

Hi MMW,

❝ Once of the clients want to conduct the partial replicate BE study with two test products (T1 & T2) in comparison with reference product (R).

More information, please. Will this be a pilot study where you want to select one of the candidates or a pivotal study (say, T1 is a tablet, T2 a capsule and you want to market both)?

• For the former see this presentation (slide 22).
  
• For the latter employ the same design but adjust for multiplicity (i.e., 95% CI, slide 23).
  If you expect a CV_wR <43% the Type I Error might be inflated. You can iteratively adjust α (see here and there) with the R-package PowerTOST. Call scABEL.ad(alpha = 0.025, design = "2x3x3", ...), where in ... you provide the observed CV_wR and sample size (in the case of drop-outs: subjects/sequence). In case of unbalanced sequences use the argument sdsims = TRUE (slower but more accurate).