long half-life and large variability [Regulatives / Guidelines]

posted by martin  – Austria, 2020-07-29 16:57 (367 d 10:49 ago) – Posting: # 21798
Views: 2,190

Dear all,

I would appreciate the forum members thoughts on the following situation.

In short:My interpretation of regulatoy guidelines: adding additional fixed effect factors to the factors mentioned in the guidelines is typically considered as not acceptable by regulators.

best regards & looking forward to some ideas to potentially address this situation

martin

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Sunday 03:46 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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