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durga09 ☆ India, 2023-09-08 12:21 (391 d 21:18 ago) Posting: # 23712 Views: 3,480 |
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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 (390 d 18:55 ago) @ durga09 Posting: # 23714 Views: 3,040 |
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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 (389 d 11:43 ago) @ Achievwin Posting: # 23715 Views: 3,000 |
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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 ) |
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durga09 ☆ India, 2023-10-10 12:43 (359 d 20:56 ago) @ mittyri Posting: # 23748 Views: 2,656 |
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❝ 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 Thank you AchievWin and mittyri. Need a small help in the Output. In output I am getting Confidence intervals as Hodges-Lehmann Estimation:But as per guideline Tmax 90% CI should me 0.80 to 1.25 by this point does the study "pass" or "fail" How can interpret the results? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Tabulators changed to spaces and BBcoded; see also this post #6. [Helmut] |
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mittyri ★★ Russia, 2023-10-11 14:55 (358 d 18:44 ago) @ durga09 Posting: # 23750 Views: 2,606 |
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Dear Durga! ❝ Need a small help in the Output. In output I am getting Confidence intervals as ❝ ❝ ❝ Type 90% Confidence Limits ❝ Asymptotic (Moses) -0.5000 1.5000 ❝ Exact -0.5000 1.5000 ❝ ❝ But as per guideline Tmax 90% CI should me 0.80 to 1.25 by this point does the study "pass" or "fail" ❝ ❝ How can interpret the results? I've never seen any acceptance limits for Tmax in any guidelines. Could you please educate me - where is it from? Note that we are comparing the differences in Tmax, so usual limits could not be applied for Tmax comparison. From your results, since CI includes zero, one may conclude that the null hypothesis of statistical difference of T and R Tmax could not be rejected with given significance level. — Kind regards, Mittyri |
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Helmut ★★★   Vienna, Austria, 2023-10-12 08:55 (358 d 00:44 ago) @ durga09 Posting: # 23751 Views: 2,558 |
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Hi Durga, ❝ But as per guideline Tmax 90% CI should me 0.80 to 1.25 by this point does the study "pass" or "fail" See this presentation as a starter. I guess you are referring the EMA’s product specific guidances on ibuprofen, paracetamol, and tadalafil. Adding to what Mittyri wrote, perhaps this article helps. Jiří Hofmann gave a presentation about tmax and partial AUCs at this year’s BioBridges conference (Prague, 21/22 September). It’s not online yet. Check the Archive till the 2023 link will appear. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz