Bioequivalence and Bioavailability Forum • Two-stage replicate design studies for RSABE

Two-stage replicate design studies for RSABE [Design Issues]

posted by Achievwin – US, 2021-05-14 21:20 (1074 d 17:56 ago) – Posting: # 22354
Views: 2,264

Does anyone have knowledge or experience in conducting two stage adaptive study for a four period full replicate design study for RSABE candidate?

Has anyone conducted this kind of study (due to Covid or other reasons)
What kind of statistical analysis is best for two stage design. Stage 1 or Stage 1+2 data presented separately what penalty we need to incorporate in Stage 1+2 pooled data for evaluating RSABE?

Thanks for all suggestions

Edit: Category changed; see also this post #1. [Helmut]

Two-stage replicate design studies for RSABEAchievwin 2021-05-14 19:20
- Two-stage design ❌ RSABE Helmut 2021-05-14 20:14
  - Two-stage design ❌ RSABE Achievwin 2021-05-19 19:08
    - Two-stage design & RSABE: Forget it! Helmut 2021-05-19 20:40