Bioanalysis of dropouts, etc. [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-04-01 17:56 (4992 d 04:01 ago) – Posting: # 4997
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Dear Dan!

I agree essentially with all your points, but I would strongly suggest to analyze all samples of dropouts (and even samples of subjects withdrawing consent) as well. I wouldn’t restrict analysis to subjects experiencing AEs. See this thread (especially the end of Ohlbe’s post). If any regu­la­tory authority asks you for PK data of these samples – and you don’t have them “handy”, you will be in a bad position (long-term stability exhausted or the samples are even already discarded).
Another often forgotten point: If a subject drops out at t > tmax in the last period, this subject may serve well in the comparison of Cmax – only AUC is not evaluable (I’ve seen people excluding all data of such subjects from the evaluation – decreasing the power of the study).

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