Bioequivalence and Bioavailability Forum

Couple of sample size questions [Power / Sample Size]

posted by BE-proff – Russia, 2020-11-04 08:21 (319 d 19:00 ago) – Posting: # 22054
Views: 1,018

Hi All

I have a couple of questions:

1. I wanna do BE study in european population but all PK data from literature have been obtained from asian volunteers.
   Is it applicable/correct to use such data for my study sample size calculation?
   
   
2. We know that the higher number of subjects the higher chances to pass BE. But on the other hand higher subjects will need higher budget which is not good.
   Are there any statstical methods to find the optimal decision in such situations?

Complete thread:

• Couple of sample size questionsBE-proff 2020-11-04 08:21 [Power / Sample Size] 
  • Couple of answers Helmut 2020-11-04 11:27
    • Couple of answers BE-proff 2020-11-04 16:50