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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
❝ ...should read "For drug A...", or?
No. For the test treatment of drug A the difference between the two studies was actually lower than that.
❝ Which agency do you wanna go with these data?
❝
❝ Experienced CRO? Some sponsor audits throughout the studies or after obtaining such results?
What I'm questioning is not even the results from this specific study, but yes, it was audited and no problem was found. I'm trying to understand whether that is a concern point for bioequivalence in general. The big question would be "how many studies have passed with 28 subjects or less and shouldn't pass actually?" or "how many studies have failed with 28 subjects or less and should pass actualy?". You see that the variability for both drugs in the pilot studies was not very high for the N used, so we would expect it to be predictive.
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 StudyLucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
- Approved Pilot and Failed Pivotal StudyLucas 2014-03-17 18:55
- 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 nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- 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 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 Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
Ing. Helmut Schütz