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

posted by ElMaestro  – Belgium?, 2020-07-30 08:17 (83 d 00:40 ago) – Posting: # 21802
Views: 1,198

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.

I could be wrong, but...

Best regards,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

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