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Elena ☆ Macedonia, 2013-05-22 00:07 (4766 d 06:57 ago) Posting: # 10613 Views: 4,972 |
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Hi, At this moment, would you include partialAUC in a protocol for a single dose be study for a prolonged release tablet, or you would stick to the old guideline for the time being (till the draft is finalized) regarding the parameters to be analyzed ? Thank you! |
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jag009 ★★★ NJ, 2013-05-22 17:15 (4765 d 13:50 ago) @ Elena Posting: # 10616 Views: 3,819 |
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Hi, ❝ At this moment, would you include partialAUC in a protocol for a single dose be study for a prolonged release tablet, or you would stick to the old guideline for the time being (till the draft is finalized) regarding the parameters to be analyzed ? FDA? Yes I would include the partial AUCs John |
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Elena ☆ Macedonia, 2013-05-22 18:19 (4765 d 12:45 ago) @ jag009 Posting: # 10619 Views: 3,836 |
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❝ FDA? Yes I would include the partial AUCs Hi, Thank's for the answer. But I was referring to the new EU guideline for BE on modified release. Any thoughts for the EU? Thanks, 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! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2013-05-23 18:12 (4764 d 12:52 ago) @ Elena Posting: # 10631 Views: 4,143 |
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Hi Elena, ❝ But I was referring to the new EU guideline for BE on modified release. Any thoughts for the EU? In the draft the PK-group want us to show pAUCs for all MR formulations in single dose if no accumulation is predicted (AUCτ >90% of AUC∞) and therefore, no MD study will be required. “In this case bioequivalence needs to be demonstrated for additional parameters representing the shape of the plasma concentration versus time curve in the single dose study […].” I don’t see a justification for the suggested truncation at τ/2 (see also this post). Note that for multiphasic products pAUCs are already required since Feb. 2012 (Rev. 4 of the Q&A document). In my understanding (see here) we will only have to report the two Cmax values, but not statistically compare them.Since this is a draft, currently only the ‘old’ MR-GL and the Q&A are applicable. — 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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Dr_Dan ★★ Germany, 2013-05-24 11:50 (4763 d 19:14 ago) @ Elena Posting: # 10639 Views: 3,715 |
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Hi Elena If you want to assess partial AUC as primary parameter you need to keep in mind that the intra-subject variability of the partial AUC is different from AUCt and AUCinf and could be much higher than the intra-subject variability of Cmax. Consequently you would need much more subjects in a BE study to demonstrate equivalence i.e. the 90 CI of partial AUC within the acceptance range. I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz