Washout based on mean ± SD of t½ [Design Issues]

posted by Imph – 2022-09-26 17:24 (549 d 16:46 ago) – Posting: # 23320
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Hi,

Thank you very much for your valuable informations.

I would like to know if this method can be applied to each pharmacokinetic measurement, for example to determine the duration of the sampling (5 x t1/2) or to calculate the predose limit of 5% Cmax when the Cmax is provided in the literature under mean+/-SD.

Why plan for 95% coverage (z0.95 = 1.96), is it related to alpha =5%.

In the reference you gave, a normal distribution is assumed, but pharmacokinetic measurements do not generally follow a normal distribution but a log-normal one. Does this method still apply?

Thank you verry much.

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