Still SF [Two-Stage / GS Designs]

posted by VStus – Poland, 2016-10-06 22:53 (1677 d 09:43 ago) – Posting: # 16703
Views: 11,405

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

Complete thread:

Activity
 Admin contact
21,446 posts in 4,483 threads, 1,511 registered users;
online 14 (0 registered, 14 guests [including 11 identified bots]).
Forum time: Tuesday 08:36 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5