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rana ☆ India, 2012-01-05 15:30 (4867 d 20:27 ago) Posting: # 7866 Views: 4,704 |
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Whether it is possible to Truncate AUC upto 72.0 hrs in modified release formulations??? Regards, Rana. Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2012-01-05 20:06 (4867 d 15:51 ago) @ rana Posting: # 7868 Views: 4,065 |
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Dear Rana! ❝ Whether it is possible to Truncate AUC upto 72.0 hrs in modified release formulations??? Good point. Please give us more details – MR is a too general term. Personal views: For delayed release and some kind of pulsatile formulations it should not be a problem (latest phase of the profile = elimination). For controlled release going beyond flip flop PK (latest phase = absorption!) I would be very wary. It seems that EMA in the new MR guideline will ask for AUC∞. — 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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raoofkhan ● 2012-01-09 21:29 (4863 d 14:28 ago) @ rana Posting: # 7886 Views: 3,781 |
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❝ Whether it is possible to Truncate AUC upto 72.0 hrs in modified release formulations??? Dear Rana, If the plasma concentration remains at appreciable levels, which may be the case for long half-life drugs, the truncation may lead to difficulties of interpretation and correlating factual figures. Raoof Khan |
Ing. Helmut Schütz