Category now obsolete? EMEA on non-parametrics [Nonparametrics]

posted by ElMaestro  – Denmark, 2008-08-22 15:23 (6505 d 08:06 ago) – Posting: # 2229
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Good point, DLabes.
First: "In studies to determine bioequivalence after a single dose, AUCt, AUCoo, Cmax and tmax should be determined."
And then later:
"The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for the parameters under consideration."
One could get the impression that the pharmacokinetolophystic subgroup is requesting a parametric analysis of tmax including 90% CI's and the works, had it not been for the final punch:
"In studies to determine bioequivalence after a single dose, the parameters to be analysed are AUCt and Cmax."
...so why do they want tmax at all?

EM.

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