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RegisterEMA product specific guidances [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2014-01-13 14:48 (4551 d 11:54 ago) – Posting: # 12161
Views: 2,967
Dear Dan,
Maybe. Some comments over there.
Sorafenib, right? That’s weird indeed.
❝ […] 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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA product specific guidelines Dr_Dan 2014-01-13 11:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA product specific guidancesHelmut 2014-01-13 13:48
Ing. Helmut Schütz