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

posted by ElMaestro  – Belgium?, 2019-07-17 21:02  – Posting: # 20384
Views: 249

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.

I could be wrong, but...
Best regards,
ElMaestro

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,685 posts in 4,176 threads, 1,351 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 01:38 CEST

Normality is a myth; there never was, and never will be,
a normal distribution.    Roy C. Geary

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5