neglecting periods for Tmax [Nonparametrics]

posted by mittyri – Russia, 2018-11-16 21:52 (712 d 21:54 ago) – Posting: # 19641
Views: 4,009

Dear 0521,

» 3. If I use the method of the paper to test Tmax, only the "3.2 treatment test" is meaningful when the P value of the "3.1 sequence test" sequence effect is >0.05
Citing Hauschke et al.1):
When assessing treatment effects, the fundamental assumption is the absence of carryover effects, which would again imply a reformulation of the test problem to ensure applicability of a direct test approach. For the sake of simplicity, it has been proposed to use a more liberal significance level for the above test, for example p = 0.10; see also Jones and Kenward (2003) for a further discussion of this indirect approach. A direct approach for testing the absence of a relevant difference in carryover effects has been proposed by Wellek (2003). However, as discussed later in Chapter 4, carryover effects can be excluded in bioequivalence studies based on medical grounds since healthy volunteers are recruited and an adequate washout has to be chosen.


» 6. Does it mean that the method in the paper as a whole is more extensive than the data applied by the "Wilcoxon signed rank test". In other words, the method in the paper has fewer assumptions than the "Wilcoxon signed rank test".:confused:
Well, I would say to neglect period effects after Hauschke2) proposal is out of date.


1 Hauschke D, Steinijans VW and Pigeot I.
Bioequivalence studies in drug development methods and applications. John Wiley & Sons, New York (2007).
2 D. HAUSCHKE, V. W. STEINIJANS and E. DILETTI
A distribution-free procedure for the statistical analysis of bioequivalence studies
International Journal of Clinical Pharmacology, Therapy and Toxicology,
Vol. 28 No. 2 -1990 (72-78) / Vol.30, Suppl. No. 1 -1992 (pp,S37-43)

Kind regards,
Mittyri

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,477 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Thursday 19:46 UTC (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5