Bioequivalence and Bioavailability Forum

Failed study [Study Assessment]

posted by myy – Germany, 2014-03-08 22:40 (4082 d 11:17 ago) – Posting: # 12582
Views: 10,031

❝ Since the test product fails to meet only the lower end of the criteria for AUC 0-t it is not truely bioinequivalent. Could it be possible that bioinequivalence was demonstrated accidentally although the two products are

❝ actually bioequivalent? How could this be proven?

❝

❝ Careful with the terminology. Bioinequivalence was not shown. Your product could be BE, it has just not been demonstrated. Bioinequivalence is only if the CI is entirely outside the acceptance range.

Could this also be argued in front of regulatory authorities?

Complete thread:

Failed study myy 2014-03-07 16:19
- No sample size estimation in protocol? Helmut 2014-03-07 16:47
  - No sample size estimation in protocol? myy 2014-03-08 21:32
- Failed study ElMaestro 2014-03-07 17:20
  - Failed study nobody 2014-03-07 18:02
  - Failed studymyy 2014-03-08 21:40
    - Failed study Dr_Dan 2014-03-10 17:36
- Failed study Dr_Dan 2014-03-07 19:21
  - Failed study myy 2014-03-08 22:04
    - Failed study Dr_Dan 2014-03-10 17:44

Failed study [Study As­sess­ment]

Complete thread:

Failed study [Study Assessment]