Bioequivalence and Bioavailability Forum

Failure of BE in fasting studies [Study Assessment]

posted by Dr_Dan – Germany, 2012-10-10 15:09 (5012 d 00:14 ago) – Posting: # 9374
Views: 12,498

Dear Chirag
why shouldn't regulatory authorities accept two different designs? Bioequivalent is bioequivalent regardless if this is demonstrated by replicate or two way cross-over design. The reason why two different designs (+ blood sampling time points) were choosen is easily explained. To be on the safe side you should use the same batches of test and reference in both studies conducted at the same CRO (one site and one analytical method).
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

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 studiesDr_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

Failure of BE in fasting studies [Study As­sess­ment]

Complete thread:

Failure of BE in fasting studies [Study Assessment]