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mokhtar saleh ☆ Egypt, 2017-10-24 14:58 Posting: # 17912 Views: 3,299 |
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Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ??? I mean in a Bioequivalence study the C.I of cmax and AUC0-t were in the accepted range of Bioequivalence but AUC0-inf outside the range, can the study be accepted?? Although the drug is not a highly variable drug???? Edit: Please follow the Forum’s Policy. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2017-10-24 15:14 @ mokhtar saleh Posting: # 17913 Views: 2,861 |
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Salam Mokhtar, » Is AUC0-inf a primary parameter for assessing Bioequivalence or secondary ??? Depends on what is stated in your statistical analysis plan.  For the FDA you have to demonstrate BE for Cmax, AUC0–t, and AUC0–∞. In most other jurisdictions only Cmax are AUC0–t required. » […] the C.I of cmax and AUC0-t were in the accepted range of Bioequivalence but AUC0-inf outside the range, can the study be accepted?? In many cases the variability of these PK metrics ranks Cmax > AUC0–∞ > AUC0–t. Hence, passing Cmax but failing AUC0–∞ is unlikely but possible. » Although the drug is not a highly variable drug???? Doesn’t matter. P.S.: Your keyboard’s got jammed numerous times. You should repair or replace it. — Cheers, 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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mokhtar saleh ☆ Egypt, 2017-10-24 16:29 @ Helmut Posting: # 17914 Views: 2,810 |
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Thank you doctor But are there any country or guidance stat AUCinf as a primary parameter?? Edit: See this post #3. [Helmut ≠ doctor] |
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jag009 ★★★ NJ, 2017-10-27 03:42 @ mokhtar saleh Posting: # 17932 Views: 2,711 |
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» But are there any country or guidance stat AUCinf as a primary parameter?? He said that already. FDA=USA needs BE for Cmax, AUCt and AUCi J |
Ing. Helmut Schütz