Still SF [Two-Stage / GS Designs]

posted by VStus – Poland, 2016-10-06 22:53 (1809 d 05:40 ago) – Posting: # 16703
Views: 11,604

Hello Maestro,

» Nitpicking: you perform a 2-stage trial or a pilot trial because you do not know the variability, right? Which means the "let's say 50% power" in actuality means guessworking.

Well, when we start generic development, in best case we have only data published by Originator in NDA or SmPC, and there may be one or two trials comparing phase 3 and commercial formulation or 2x2 mg vs. 1x4mg... Which we may use as inputs for our guesstimate of Intra-subject CV. We never know it in advance. T/R is also just an assumption...
"Intra-subject CV is not carved in stone".

So someone can say it's always a guessworking untill we receive data from our own trial(s) to improve precision of it.

Regards, VStus

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