Bioequivalence and Bioavailability Forum

Different designs: why not? [Study Assessment]

posted by Helmut – Vienna, Austria, 2012-10-10 15:48 (5012 d 07:14 ago) – Posting: # 9376
Views: 12,428

Dear Chirag,

agree with what Dan said above. We once performed a fasting study in a parallel design (long half life according to the literature). The long half life turned out to be nonsense. I guess the analytical method in the publication had some selectivity issues and measured parent + one minor metabolite. Consequently we performed the fed study in a cross-over. No problem.

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Complete thread:

Failure of BE in fasting studies ABE1580 2012-10-09 15:42
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
  - Failure of BE in fasting studies cakhatri 2012-10-10 07:34
    - Failure of BE in fasting studies Dr_Dan 2012-10-10 13:09
    - Different designs: why not?Helmut 2012-10-10 13:48
      - Different designs: why not? cakhatri 2012-10-12 10:42
    - Failure of BE in fasting studies drgunasakaran1 2012-10-10 19:14
      - Failure of BE in fasting studies ABE1580 2012-10-11 06:10
  - Failure of BE in fasting studies drsinghs 2012-10-11 09:28
    - Failure of BE in fasting studies Dr_Dan 2012-10-11 11:43
      - 1–β not necessarily = Δ Helmut 2012-10-11 13:05
      - Sample size d_labes 2012-10-11 13:10
        
        +partial replicate Helmut 2012-10-11 17:53

Different designs: why not? [Study As­sess­ment]

Complete thread:

Different designs: why not? [Study Assessment]