excluded period(s) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-08-16 16:36 (3447 d 12:09 ago) – Posting: # 9073
Views: 7,786

Hi Navoday!

» should we submit statistical data with inclusion and exclusion of that subject having predose concentration more than 5% of Cmax or simply delete that subject from all analysis?

Even complying with the guidance I always state the planned procedure in the protocol. I report the PK data (in order to give the assessor a mean to check them) but exclude the subject in a 2×2 cross-over from comparative assessments. If the pre-dose concentration is observed not in all periods and the study is either a replicate or a higher-order cross-over, I proceed as following:
» what if study is partial replicate (3WSABE)and that subject has completed TR sequence? as it may help for estimating t1/2 and tmax if average bioequivalence is there.

Since according to the FDA a partial replicate has to be analyzed by SAS Proc GLM (or similar) IMHO all data of the subject will be dropped from the analysis (even if you observe a pre-dose concentration in just one period).

» as it may help for estimating t1/2 and tmax if average bioequivalence is there.

Don’t understand what you mean here. :confused:

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