Bioequivalence and Bioavailability Forum

Dear All,

Request you to share your thoughts for the requirement for Type 1 error estimation and adjustment of alpha for below different scenarios.

❝ The inflation of the Type I Error depends on CV_wR (and to a minor extent on the sample size).

study is conducted as partial replicate design with 60 subjects. Now CVwr has turned out to be 31% in the study. In the sample size T/R ratio was assumed to be 0.90. In the actual conducted study T/R ratio had come to 100% (product essentially similar to reference product-Hypothetical scenario). Now study is passing the SCABE criteria. Study would have also passed incase limits would not have been scaled. Essentially there would not have been difference in study conclusion if the Scaling approach would have applied or not applied. As per my understanding Type 1 error would arise incase there is difference in study conclusion when there is uncertainty in the ISCV and due to that difference in study conclusion incase different method for study conclusion is utilized (like study passing in SCABE but failing in ABE, borderline case). DO any such case require adjustment of alpha although there is borderline high variability (incases where there is maximum probability of type 1 error).

Regards
Pjs