Still SF [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-10-06 22:13 (1717 d 16:03 ago) – Posting: # 16702
Views: 11,487

Hello VStus,

» But back to reality: isn't it more practical in case of HVD to perform pilot on development with let's say 50% power (wondering: replicated pilot to keep reasonable small population?), better understand in-vitro in-vivo relationship, optimize formulation and than run replicate scaled trial? In 2-stage we also need to wait for results from the 1st stage...

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. Optimizing the formulation on basis of a pilot trial with inherently low power (=high uncertainty on the PE) is in scientific terms as solid as tarot cards or crystal healing.
I read on LinkedIn the other day: "The flat earth society has members all over the globe" :-D:-D:-D

OK, surely I will get in trouble for this post.

Pass or fail!

Complete thread:

 Admin contact
21,530 posts in 4,499 threads, 1,523 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 14:17 CEST (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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