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

posted by martin  – Austria, 2020-07-29 18:57 (1338 d 21:53 ago) – Posting: # 21798
Views: 2,965

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
122 visitors (0 registered, 122 guests [including 6 identified bots]).
Forum time: 15:51 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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