Pilot study assessment [Study As­sess­ment]

posted by Smog – Russia, 2016-03-24 20:37 (3747 d 06:53 ago) – Posting: # 16136
Views: 7,798

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.

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