Still SF [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-10-07 00:13 (3194 d 17:26 ago) – Posting: # 16702
Views: 14,653

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...


Yes
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.
:pirate:

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,677 registered users;
44 visitors (0 registered, 44 guests [including 12 identified bots]).
Forum time: 17:39 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

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