Bioequivalence and Bioavailability Forum

Approved Pilot and Failed Pivotal Study [Study Assessment]

posted by nobody – 2014-03-18 16:55 (4484 d 10:43 ago) – Posting: # 12658
Views: 20,758

This is not about the methodology of BE-testing.

The Test product might have changed (scale-up), the clinics might have screwed up (so so many possible ways...).

You need a lot of detailed data (from in vitro to clinical records) to learn what went wrong in such a case.

—
Kindest regards, nobody

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 Study Lucas 2014-03-18 14:03
        
        Approved Pilot and Failed Pivotal Studynobody 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]