Bioequivalence and Bioavailability Forum • Objective? (again)

Objective? (again) [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-09-17 15:51 (4257 d 11:17 ago) – Posting: # 11506
Views: 7,812

Hi RK,

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

❝ We already have conducted a fully replicated study with two sequences (ABAB and BABA) but the study did not meet bioequivalence, […]

Why did the study fail? Ratio too far away from one? Variability higher than expected? If the answer to both is no, pure chance? 80% power = 20% chance to fail to show BE.

❝ […] now the client is planning for a repeat fully replicated study with six sequences (AABB, BBAA, ABAB, BABA, ABBA, BAAB).

Try to answer my questions above. “The client wants it” is no valid justification.

❝ […] the regulatory acceptance (USFDA) and the implication on going ahead with this study design and statistical analysis.

FDA argued even against the four-period four-sequence design TRRT|RTTR|TTRR|RRTT in the Guidance’s Appendix B.

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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