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

posted by martin  – Austria, 2020-07-29 22:49 (16 d 05:13 ago) – Posting: # 21801
Views: 797

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

Martin

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