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durga09 ☆ India, 2023-09-08 12:21 (18 d 19:27 ago) Posting: # 23712 Views: 389 |
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Dear All, 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. Regards, Durga |
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Achievwin ★ US, 2023-09-09 14:44 (17 d 17:03 ago) @ durga09 Posting: # 23714 Views: 319 |
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❝ 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  ) 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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mittyri ★★ Russia, 2023-09-10 21:55 (16 d 09:52 ago) @ Achievwin Posting: # 23715 Views: 264 |
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Dear AchievWin, Dear Durga, I would point to the classical post (I'd say golden collection of this forum) provided by Detlew and Helmut here. It is 13 years old, but it is still the best. And the article mentioned there is 33 years old and also no one provided something better ) |
Ing. Helmut Schütz