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

posted by martin  – Austria, 2020-07-29 16:57 (789 d 07:58 ago) – Posting: # 21798
Views: 2,622

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
22,390 posts in 4,685 threads, 1,594 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Tuesday 00:56 CEST (Europe/Vienna)

Statistics. A sort of elementary form of mathematics which consists of
adding things together and occasionally squaring them.    Stephen Senn

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