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

posted by ElMaestro  – Denmark, 2019-07-17 23:02 (1738 d 01:13 ago) – Posting: # 20384
Views: 2,800

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
22,988 posts in 4,825 threads, 1,656 registered users;
94 visitors (0 registered, 94 guests [including 5 identified bots]).
Forum time: 00:16 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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