Bioequivalence and Bioavailability Forum

T/R ratio for estimation of sample size in BE study of NTI drugs [Power / Sample Size]

posted by nobody – 2017-10-26 16:03 (3155 d 11:16 ago) – Posting: # 17921
Views: 9,143

...to be true: I would support discouraging the use of defaults without any knowledge on the actual products (dissolution, pharmaceutical quality etc.). Planning a BE-study should involve that you know that the "correct" GMR / sample size is hindsight knowledge and one way or the other there is a risk to loose money (too many volunteers, too little power to conclude BE), one way ore the other...

Complete thread:

• T/R ratio for estimation of sample size in BE study of NTI drugs mahmoud-teaima 2017-10-24 19:18 
  • T/R ratio for estimation of sample size in BE study of NTI drugs Helmut 2017-10-24 23:15
    • T/R ratio for estimation of sample size in BE study of NTI drugs ElMaestro 2017-10-25 12:34
      • T/R ratio for estimation of sample size in BE study of NTI drugsnobody 2017-10-26 14:03
        • Defaults in PowerTOST d_labes 2017-10-26 14:49