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

posted by Helmut Homepage – Vienna, Austria, 2020-08-12 15:53 (736 d 05:12 ago) – Posting: # 21865
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Hi Achievwin,

» Welcome to the home of funky and funny pharmacokinetics where "Garbage in Gospel out" is day of life.

:-D

» 1. allowing long washout periods have seen studies with 4 -5 months washout.

Seen a couple as well.

» 2. other choice we can imagine is Two stage adaptive study design and including ANCOA in place of ANOVA...

Slippery grounds – nothing published. You are on your own to demonstrate that the Type I Error is controlled. For the FDA and Health Canada likely simulations are sufficient. For the EMA no way.
I’m a fan of TSDs but if you proceed to the second stage it more than doubles the time of study compared to a fixed sample design. With fast to moderate half lives not an issue. But here?

Furthermore, reference-scaling for HVD(P)s in a TSD is not possible. Some tried, all studies were rejected due to potential inflation of the TIE.

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