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Hello to everybody!
I have a little question regarding the pilot study (2x2x2, 11 subjects). The point estimate for the Cmax was 116.97. CI is: LL 95,28, UL 146,01 in the pilot study. The drug is not HVD.
Is there any sence to go forward with pivotal study in case of such GMR? If so which GMR to use: 0,95 or 1,1697?
Thank you in advance for your help.
I have a little question regarding the pilot study (2x2x2, 11 subjects). The point estimate for the Cmax was 116.97. CI is: LL 95,28, UL 146,01 in the pilot study. The drug is not HVD.
Is there any sence to go forward with pivotal study in case of such GMR? If so which GMR to use: 0,95 or 1,1697?
Thank you in advance for your help.
Complete thread:
- Pilot study assessmentSmog 2016-03-24 19:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Nasty PE ⇒ reformulate… Helmut 2016-03-25 15:53
- Pilot study assessment ElMaestro 2016-03-27 18:07
Ing. Helmut Schütz