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

posted by martin  – Austria, 2020-07-29 22:49 (92 d 16:41 ago) – Posting: # 21801
Views: 1,237

dear ElMaestro,

Thank you for your swift reply and sharing your thoughts.

There are two types of covariates (type 1: continous = subject specfic values; and type 2: categorical variable with a few levels).

At the first glance a different regulatory pathway might be worth considering based on a PK or exposure similarity evalulation as in such a case there could be more flexibility regarding acceptance of statistical models used to test for equivalence in PK metrics.

Happy to get your thoughts on this idea.

best regards


Complete thread:

 Admin contact
21,180 posts in 4,415 threads, 1,476 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).
Forum time: Friday 14:30 CET (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

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