Bioequivalence and Bioavailability Forum

Failed study [Study Assessment]

posted by Dr_Dan – Germany, 2014-03-10 18:36 (4140 d 13:35 ago) – Posting: # 12584
Views: 10,268

❝ Could this also be argued in front of regulatory authorities?

IMHO this will not be possible. For sample size calculation you assume a formulation difference of <5%. In case of Cmax this holds true whereas in case of AUC the T/R ratio is >10%. You could demonstrate bioequivalence but as Helmut demonstrated you would need an unethical high number of subjects since the study have to be overpowered to get the desired result.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

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 study myy 2014-03-08 21:40
    - Failed studyDr_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]