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

posted by ElMaestro  – Denmark, 2020-07-30 08:17 (419 d 19:36 ago) – Posting: # 21802
Views: 1,852

Hi mrtin,

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

Type 2 sounds like the very thing that I would call a fixed factor. :-)

» 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.

I would always recommend to approach regulators for a discussion. They will always listen but not always agree.

Injectable? Sometimes surface area or body weight is reasonable for exposure modeling. That's a covariate in the word's best sense :-) As in, a continuous variable. If multiple periods or longitudinal study, a covariates like bw may change over time.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,691 posts in 4,534 threads, 1,541 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 03:54 CEST (Europe/Vienna)

Learning is a lifetime process, but there comes a time
when we must stop adding and start updating.    Robert Brault

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