Tmax 90% confidence interval [Regulatives / Guidelines]

posted by Achievwin – US, 2023-09-09 14:44 (308 d 13:48 ago) – Posting: # 23714
Views: 2,490

❝ Could anyone please help me with example or article or program, on how to calculate below point as per Ibuprofen EMA guideline.


❝ 1) 90% confidence interval: Comparable median (≤ 20% difference, 80.00–125.00%) and range for Tmax.


Helmut responded to your question awhile ago, the following paper discuss these details.

ADJUSTING PAIRWISE NONPARAMETRIC EQUIVALENCE HYPOTHESIS TESTS AND CONFIDENCE INTERVALS FOR PERIOD EFFECTS IN 3×3 CROSSOVER TRIALS

Luc Duchateau, Paul Janssen, Roel Straetemans & Christian Otoul, Journal of Biopharmaceutical Statistics Volume 12, 2002 - Issue 2 Pages 149-160 | Received 01 Mar 2002, Accepted 01 May 2002, Published online: 05 Oct 2011 (what is interesting is that this paper was accepted in 2002 and published in 2011 - like some of our harmonization guidance :-D)

Coming to your question there is a sas code on how to non parametric estimates and calculate difference and confidence, (not sure how to attach the file). Before all this was known we did parwaise rank order comparison followed by Wilcoxon t-test for tmax, t1/2 etc.

Hope this helps and Best

AchievWin

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