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kram ☆ India, 2010-01-13 12:06 (5596 d 02:39 ago) Posting: # 4591 Views: 9,692 |
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Dear All, Is it important to show AUCinfinity within range of 80-125% for Bioequivalence, and shall I exclude AUCinfinity from Bioequivalence if power is around 50 % and other PK parameter like Cmax and AUClast are within 80-125% and AUCinfinity is out of range ? Best Regards, Ram |
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Ohlbe ★★★ France, 2010-01-13 12:35 (5596 d 02:09 ago) @ kram Posting: # 4592 Views: 8,162 |
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Dear Ram, ❝ Is it important to show AUCinfinity within range of 80-125% for Bioequivalence, For which country are you conducting this study ? ❝ shall I exclude AUCinfinity from Bioequivalence if power is around 50 % and other PK parameter like Cmax and AUClast are within 80-125% and AUCinfinity is out of range ? Whatever you do should be pre-defined in your protocol, not decided based on the results of the study. Regards Ohlbe |
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kram ☆ India, 2010-01-13 14:15 (5596 d 00:29 ago) @ Ohlbe Posting: # 4594 Views: 8,070 |
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Dear Ohlbe, Thanks for reply, ❝ For which country are you conducting this study ? For Europe, we are conducting the study... is this can change your answer? Best Regards, |
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Ohlbe ★★★ France, 2010-01-13 18:36 (5595 d 20:09 ago) @ kram Posting: # 4599 Views: 7,935 |
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Dear Ram, ❝ For Europe, we are conducting the study... ❝ is this can change your answer? Yes. The FDA guideline recommends that both AUCt and AUCinf be used to measure total exposure. No chance to put AUCinf aside for FDA submissions (at least according to the guideline). The current EMA guideline considers AUCt to be "the most reliable reflection of the extent of absorption". Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2010-01-13 15:23 (5595 d 23:22 ago) @ kram Posting: # 4596 Views: 8,188 |
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Dear Ram! ❝ and shall I exclude AUCinfinity from Bioequivalence if power is around 50 % … ? Forget about 'power' (except in sample size planning, of course); see this post (and search for other posts). I know that this value is given in the output of Phoenix/WinNonlin – but please forget it. The outcome of a BE study is dichotomous – either you have demonstrated BE (confidence interval within the acceptance range), or not. I agree with Ohlbe’s statement about following the protocol – but exclusion based on ‘lacking power’ would be a flawed concept anyway. — 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