Statistical comparison of dissolution profiles - variable nr of units [Dissolution / BCS / IVIVC]

posted by ElMaestro  – Denmark, 2019-07-17 23:02 (2514 d 00:30 ago) – Posting: # 20384
Views: 5,153

Hi MSimoes,

❝ I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?


That should generally be ok, in my experience.
—
Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
408 visitors (0 registered, 408 guests [including 40 identified bots]).
Forum time: 23:32 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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