Bioequivalence and Bioavailability Forum • Objective?

Objective? [RSABE / ABEL]

posted by RK – India, 2013-09-17 15:35 (4257 d 06:44 ago) – Posting: # 11505
Views: 7,917

❝ What are you trying to achieve? Why do you think such a design would have advantages over RTRT|TRTR?

Hi all,

We already have conducted a fully replicated study with two sequences (ABAB and BABA) but the study did not meet bioequivalence, now the client is planning for a repeat fully replicated study with six sequences (AABB, BBAA, ABAB, BABA, ABBA, BAAB). As the discussions are in its initial stage would like to know the regulatory acceptance (USFDA) and the implication on going ahead with this study design and statistical analysis.

Regards
RK.

Complete thread:

fully replicate design with six sequences RK 2013-09-14 12:17
- Objective? Helmut 2013-09-15 13:47
  - Objective? jag009 2013-09-16 17:24
  - Objective?RK 2013-09-17 13:35
    - Objective? (again) Helmut 2013-09-17 13:51
      - Question: jag009 2013-09-17 15:49
        
        Imbalanced/incomplete sequences Helmut 2013-09-18 17:32
      - fully replicate design with four sequence RK 2013-09-20 13:56
        
        Period effects and sequences unrelated d_labes 2013-09-23 08:44
        
        Period effects and sequences unrelated RK 2013-09-24 13:16