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madhurak ☆ 2009-08-20 09:58 (6145 d 03:01 ago) Posting: # 4072 Views: 5,300 |
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hi, I am Madhura from mumbai. suppose in bioequivalence study for parameters Cmax, AUC0-t and AUCinf bioequivalence is in acceptance range of 80-125. But the treatment effect is significant so please tell me what can be reason for it. And how can we interpret it. regards, Madhura Khare  Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2009-08-20 17:12 (6144 d 19:47 ago) @ madhurak Posting: # 4080 Views: 4,316 |
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Dear Madhura! From the metrics you mentioned I guess you are talking about FDA's requirements? Anyhow, in bioequivalence testing for a treatment effect does not make sense (we have abandoned this concept 20 years ago). A significant treatment effect can have many causes (and combinations of them). Basically the first three of the following go back to the sample size (which was estimated in study planing based on expected CVintra, T/R-ratio, dropout-rate):
— 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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madhurak ☆ 2009-08-21 08:34 (6144 d 04:25 ago) @ madhurak Posting: # 4081 Views: 4,272 |
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then is it true that treatment effect do not have any impact on confidence interval of Cmax, AUCt, AUCinf. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post (and the Forum's Policy as well)! [Helmut] |
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ElMaestro ★★★ Denmark, 2009-08-29 18:54 (6135 d 18:05 ago) @ madhurak Posting: # 4134 Views: 4,208 |
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Hi madhurak, ❝ then is it true that treatment effect do not have any impact on confidence interval of Cmax, AUCt, AUCinf. In my opinion this is a slightly wrong kind of thinking. There certainly is a relationship between treatment effect and the confidence interval (significant treatment, CI not including 1.0). However, as has been pointed out before, a significant treatment effect is not in itself a cause of rejection. The important question if not whether your formulation differs form the originator's, rather the important question is if it differs to an extent that is important, and the latter is what the regulatory acceptance limits dictate. EM. |
Ing. Helmut Schütz