Bioequivalence and Bioavailability Forum • Parallel Group Adaptive Designs

Parallel Group Adaptive Designs [Two-Stage / GS Designs]

posted by Achievwin – US, 2024-01-05 12:53 (904 d 15:22 ago) – Posting: # 23819
Views: 13,322

I am thinking of using two stage approach for a parallel BE study (in patients) is there an accepted procedure for sample size calculations? at stage 1 and stage 2?

Any instances where FDA accepted a two stage design methodology for calculating samples size for stage 2 after reviewing stage 1 results?

Complete thread:

Parallel Group Adaptive Designs Alex 2023-12-22 10:08 [Two-Stage / GS Designs]
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
  - Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
    - Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
  - Strong Type I Error control + CI: Not yet… roman_max 2024-04-04 15:18
    - Parallel design: Only simulation-based methods so far Helmut 2024-04-04 20:16
      - Parallel design: Only simulation-based methods so far roman_max 2024-04-15 21:46
- Parallel Group Adaptive DesignsAchievwin 2024-01-05 11:53
  - Simulations highly recommended Helmut 2024-01-05 12:40
    - Simulations highly recommended Achievwin 2024-01-08 16:55
      - Simulations mandatory Helmut 2024-01-09 09:31
        
        Simulations mandatory Achievwin 2024-01-09 21:11
        
        Reviews are confidential Helmut 2024-01-09 22:10
        
        Reviews are confidential Achievwin 2024-01-19 15:11
        
        Not accepted and for a reason… Helmut 2024-04-04 20:22
        
        Quod licet Iovi mittyri 2024-04-05 20:33
        
        Non licet bovi Helmut 2024-04-05 21:50
        
        Non licet bovi mittyri 2024-04-05 22:21
        
        Quod licet bove? Helmut 2024-04-06 07:21