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Dr_Dan ★★ Germany, 2014-01-13 12:07 (4551 d 09:21 ago) Posting: # 12159 Views: 2,665 |
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Dear collegues What do you think of EMA's product specific guidelines? IMHO they did not spend much effort in the whole concept and on specific guidelines. Nice example: There is only one strength available i.e. 200 mg. The drug exhibits non-linear pharmacokinetics with a less than dose-proportional increase in AUC with increasing doses within the dose range 400-800 mg. The non-linearity is proposed to be due to limited solubility. Hence, the highest and the lowest strength should be studied.  Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2014-01-13 14:48 (4551 d 06:40 ago) @ Dr_Dan Posting: # 12161 Views: 2,967 |
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Dear Dan, ❝ […] IMHO they did not spend much effort in the whole concept and on specific guidelines. Maybe. Some comments over there. ❝ There is only one strength available i.e. 200 mg. The drug exhibits non-linear pharmacokinetics with a less than dose-proportional increase in AUC with increasing doses within the dose range 400-800 mg. The non-linearity is proposed to be due to limited solubility. Hence, the highest and the lowest strength should be studied. Sorafenib, right? That’s weird indeed. — 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