Bioequivalence and Bioavailability Forum

Approved Pilot and Failed Pivotal Study [Study Assessment]

posted by Lucas – Brazil, 2014-03-18 15:03 (4484 d 14:36 ago) – Posting: # 12657
Views: 20,772

❝ If I was the poor guy at the agency to catch such a project I would reply: Do your homework and then come back with a good explanation.

Yes, I also think so. They did not expect that the pivotal study would fail at all, that's why they didn't at least tried to submit the pilot. Once the pivotal study was done and failed, there's nothing to do, IMHO.

But once again, my doubts about this matter is how we determine a product as bioequivalent (and so efficient and safe) but that depend on the batch? If I were to test the equivalence of all the batches, would it be equivalent? Or is the N of 28 subjects not enough to safely determine the equivalence?

Complete thread:

Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
  - Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
    - Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
      - Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
        
        Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
    - Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
      - Approved Pilot and Failed Pivotal Study - same test? Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
  - Approved Pilot and Failed Pivotal Study Ohlbe 2014-03-18 11:15
  - Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
    - Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
      - Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
        
        Approved Pilot and Failed Pivotal StudyLucas 2014-03-18 14:03
        
        Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
        Approved Pilot and Failed Pivotal Study luvblooms 2014-03-19 05:16
        
        Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02

Approved Pilot and Failed Pivotal Study [Study As­sess­ment]

Complete thread:

Approved Pilot and Failed Pivotal Study [Study Assessment]