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Hello Group,
I would like to know which is the most appropriate statistical analysis
(Wilcoxon rank sum test, two one sided Wilcoxon-Mann-Whitney or
anything else? ) to be performed on Tmax for submission to USAFDA /
European region / Brazil?
Thanks & Regards,
Priti
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The following message was posted to: PharmPK
The European Guideline states
at 3.6.1 Statistical analysis
[…] If appropiate to the evaluation the analysis technique for tmax
should be non-parametric and should be applied to untransformed data.
and at 3.6.2 Acceptance range for pharmacokinetic parameters
[…] Statistical evaluation of tmax only makes sense if there is a
clinically relevant claim for rapid release or action or signs related
to adverse effects. The non-parametric 90% confidence interval for this
measure of relative bioavailability should lie within a clinically
determined range.
Recepies are given by
HAUSCHKE D., STEINIJANS V.W. and E. DILETTI;
A distribution-free procedure for the statistical analysis of
bioequivalence studies
Int. J. Clin. Pharm. Ther. Toxicol. 28, 72-78 (1990)
which is also referred in
CHOW S.-C. and J.-p. LIU;
Design and Analysis of Bioavailability and Bioequivalence Studies
Marcel Dekker, New York, pp. 110-124 (2000)
Good luck,
Helmut
Helmut Schütz Biokinet GmbH / Dept Biostatistics
Neubaugasse 36/11 Nattergasse 4
A-1070 Vienna/Austria A-1170 Vienna/Austria
tel/fax +43 1 9713935 tel +43 1 4856969 62
no cell phone ;-) fax +43 1 4856969 90
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