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RegisterPersonal experiences… [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2014-04-11 17:22 (4451 d 10:22 ago) – Posting: # 12813
Views: 6,090
Hi John,
I don’t think so – at least I never got a question from a European agency in my studies (passing BE). I simply reported the dissolution at three pHs. I neither calculated ƒ2 nor did I discuss anything.
Other experiences?
❝ Does it mean that you would have to run experiments to demonstrate the drug is class IV (run both solubility and permeability) assuming no/insufficient literature supports.
I don’t think so – at least I never got a question from a European agency in my studies (passing BE). I simply reported the dissolution at three pHs. I neither calculated ƒ2 nor did I discuss anything.
Other experiences?
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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:
- Justifications for discrepancy in dissolution vs. BE study gtomer 2014-04-09 14:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Justifications for discrepancy in dissolution vs. BE study Helmut 2014-04-10 12:31
- Justifications for discrepancy in dissolution vs. BE study jag009 2014-04-11 15:14
- Personal experiences…Helmut 2014-04-11 15:22
- Personal experiences… jag009 2014-04-11 17:58
- Personal experiences…Helmut 2014-04-11 15:22
- Justifications for discrepancy in dissolution vs. BE study jag009 2014-04-11 15:14
- Justifications for discrepancy in dissolution vs. BE study Helmut 2014-04-10 12:31
Ing. Helmut Schütz