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Paresh ☆ 2011-03-25 10:02 (5575 d 04:40 ago) Posting: # 6812 Views: 2,741 |
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Hi, is there need to calculate additional parameter AUCx and AUCx/AUCI for single dose study of Modified release product, for TPD (Canada) submission? Edit: Subject line changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2011-03-25 14:27 (5575 d 00:15 ago) @ Paresh Posting: # 6813 Views: 2,409 |
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Dear Paresh! ❝ is there need to calculate additional parameter AUCx and AUCx/AUCI for single dose study of Modified release product, for TPD (Canada) submission? Yes. See the Guideline. If the formulation is likely to accumulate with the intended dosage interval (AUCX/AUCI>0.8) additionally to single dose studies (Section 4.2) you have to perform multiple dose studies (Section 4.3). In order to make this decision, you have to know the value of AUCX/AUCI, right? — 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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Paresh ☆ 2011-03-26 11:08 (5574 d 03:33 ago) (edited on 2011-03-26 13:04) @ Helmut Posting: # 6816 Views: 2,240 |
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Hi, Thank you for your valuable response. For every MR product study need to calculate above mention parameters or decide from literature regarding accumulation of drug, than confirm from study. 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! [Ohlbe] |
Ing. Helmut Schütz