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RegisterJustifications for discrepancy in dissolution vs. BE study [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2014-04-10 14:31 (4454 d 14:53 ago) – Posting: # 12805
Views: 6,161
Hi gtomer,
in vivo BE overrules any in vitro dissimilarity (as a successful therapeutic equivalence study would overrule in vivo inequivalence). You should perform the comparative dissolution, but demonstrating in vitro similarity is not necessary. See also this thread.
I guess you mean ƒ2 <50? Either the dissolution media are not biorelevant (i.e., overdiscriminatory, since BE was proven in vivo) or dissolution is not the driving force for absorption at all (e.g., BCS classes I/IV).
in vivo BE overrules any in vitro dissimilarity (as a successful therapeutic equivalence study would overrule in vivo inequivalence). You should perform the comparative dissolution, but demonstrating in vitro similarity is not necessary. See also this thread.
❝ 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?
I guess you mean ƒ2 <50? Either the dissolution media are not biorelevant (i.e., overdiscriminatory, since BE was proven in vivo) or dissolution is not the driving force for absorption at all (e.g., BCS classes I/IV).
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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 studyHelmut 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 studyHelmut 2014-04-10 12:31
Ing. Helmut Schütz