Bioequivalence and Bioavailability Forum • Two-stage design and 'forced bioequivalence'

Two-stage design and 'forced bioequivalence' [Two-Stage / GS Designs]

posted by Mikalai – Belarus, 2018-06-06 10:28 (2928 d 09:21 ago) – Posting: # 18854
Views: 9,971

Dear all,
We plan to conduct a sequential (two stage) BE study, and I am concerned with "forced bioequivalence". Specifically, if we obtain non-equivalent results in the first stage with very low power and should recruit more volunteers, how can we protect ourselves from getting into "forced bioequivalence"? In other words, how can we differentiate between underpowered trials and non-equivalent results in the sequential BE? And how can we put this (protection against "forced bioequivalence") in the protocol not to raise many questions from regulators?
Any suggestions and advice will be appreciated.
Sincerely,
Mikalai

Complete thread:

Two-stage design and 'forced bioequivalence'Mikalai 2018-06-06 08:28
- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53
  - Two-stage design and 'forced bioequivalence' Yura 2018-06-07 10:24
    - But what is the real problem? ElMaestro 2018-06-07 13:53
      - But what is the real problem? Yura 2018-06-07 14:59
        
        But what is the real problem? Mikalai 2018-06-07 15:47
        
        But what is the real problem? Helmut 2018-06-07 17:33
        
        But what is the real problem? Mikalai 2018-06-08 12:24
        
        U as a futility criterion Helmut 2018-06-08 14:00