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RegisterJustifications for discrepancy in dissolution vs. BE study [Dissolution / BCS / IVIVC]
Hi All,
Would value your opinion:
The bioequivalence guide (CPMP/EWP/QWP/1401 Rev 1) requests to perform a dissolution profile comparison at 3 pHs between the test and reference products used in the BE study.
It gives superiority to the BE study results, should the dissolution profiles will not be similar, "However, possible reasons for the discrepancy should be addressed and justified.".
Does anyone know of any investigatory methods or justifications found for such discrepancy, i.e. where reference vs. test found similar in BE study but F2>50 in dissolution?
Many thanks.
Would value your opinion:
The bioequivalence guide (CPMP/EWP/QWP/1401 Rev 1) requests to perform a dissolution profile comparison at 3 pHs between the test and reference products used in the BE study.
It gives superiority to the BE study results, should the dissolution profiles will not be similar, "However, possible reasons for the discrepancy should be addressed and justified.".
Does anyone know of any investigatory methods or justifications found for such discrepancy, i.e. where reference vs. test found similar in BE study but F2>50 in dissolution?
Many thanks.
Complete thread:
- Justifications for discrepancy in dissolution vs. BE studygtomer 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