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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
Hi!
Yes, they've changed a lot, but not only the point estimate, the geometric means aswell. In the drug B studies the Cmax geo mean for the reference treatment changed 45% from the pilot to the pivotal. For drug B the major difference was for the Cmax of the test treatment, which changed 23%.
So when I compare RxR for drug A I get a positive result, but for drug B this does not happen, since they have a ratio of 145% for Cmax. It is noteworthy that for drug A a different batch of the reference was used in the pivotal study, but Cmax was very similar and for drug B with the same batch we got very different values for the plasma concentrations.
Standard 2x2 Xover actually.
❝ Apparently the point estimates have changed quite a bit! Could you compare Reference-pilot and Reference-pivotal to get a feeling for these products?
Yes, they've changed a lot, but not only the point estimate, the geometric means aswell. In the drug B studies the Cmax geo mean for the reference treatment changed 45% from the pilot to the pivotal. For drug B the major difference was for the Cmax of the test treatment, which changed 23%.
So when I compare RxR for drug A I get a positive result, but for drug B this does not happen, since they have a ratio of 145% for Cmax. It is noteworthy that for drug A a different batch of the reference was used in the pivotal study, but Cmax was very similar and for drug B with the same batch we got very different values for the plasma concentrations.
❝ Replicate designs employed?
Standard 2x2 Xover actually.
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27 [Study Assessment]
![[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 StudyLucas 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 Lucas 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 StudyLucas 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