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Ibrahim Komeil ☆ Egypt, 2021-02-15 11:07 (1164 d 16:14 ago) Posting: # 22208 Views: 1,733 |
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Dear All I hope you are all fine Recently i had got results of bioequivalence study for Glimepride Tablet 1 mg applying two way crossover design with 26 volunteers The results are shown below: Cmax: PI = 0.75, 90% CI [0.672 - 0.845] AUCt: PI = 0.82, 90% CI [0.754 - 1.042] I am confusing to be sure that the test product is bad , so i am asking your help to know the real cause of these results. Thank you in advance Edit: Category changed; see also this post #1. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2021-02-15 11:59 (1164 d 15:22 ago) @ Ibrahim Komeil Posting: # 22209 Views: 1,407 |
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Hi Ibrahim, ❝ I am confusing to be sure that the test product is bad, so i am asking your help to know the real cause of these results. Difficult to guess the ‘real cause’ but repeating the study in a larger sample size – given the point estimates – is futile. Even if you believe that the result were due to chance and hope that the point estimates will shift to 0.85 you would need hundreds of subjects to show BE with 80% power. BTW, the CV of AUC (~0.351) is larger than the one of Cmax (~0.245). Possible but uncommon. — 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 |
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Ibrahim Komeil ☆ Egypt, 2021-02-16 00:48 (1164 d 02:33 ago) @ Helmut Posting: # 22210 Views: 1,359 |
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Thank you very much for your reply 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! [Helmut] |
Ing. Helmut Schütz