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RegisterDiosmetin as a surrogate [Regulatives / Guidelines]
Dear forum members,
I would appreciate your opinion regarding following query:
Current EU guideline on BE discourages from the use of a metabolite as a surrogate for parent compound, pointing it can be accepted only exceptionally.
This might be the case of Diosmin products for which determination of Diosmin in human plasma is impossible. Even the determination of Diosmin’s aglicon – free Diosmetin – has proven to be difficult due to its low concentrations, for most of Diosmetin is present in the blood as glucuronide.
The solution might be represented by enzymatic degradation of plasma samples applied to conjugated Diosmetin.
I am just wondering whether this kind of surrogate – free Diosmetin obtained after enzymatic degradation – can be viewed as the acceptable one.
Looking forward to your view!
Jana
I would appreciate your opinion regarding following query:
Current EU guideline on BE discourages from the use of a metabolite as a surrogate for parent compound, pointing it can be accepted only exceptionally.
This might be the case of Diosmin products for which determination of Diosmin in human plasma is impossible. Even the determination of Diosmin’s aglicon – free Diosmetin – has proven to be difficult due to its low concentrations, for most of Diosmetin is present in the blood as glucuronide.
The solution might be represented by enzymatic degradation of plasma samples applied to conjugated Diosmetin.
I am just wondering whether this kind of surrogate – free Diosmetin obtained after enzymatic degradation – can be viewed as the acceptable one.
Looking forward to your view!
Jana
Complete thread:
- Diosmetin as a surrogateJana Zigova 2015-02-10 09:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Metabolite(s) to demonstrate BE Helmut 2015-02-10 12:18
- EMA: Metabolite(s) to demonstrate BE Jana Zigova 2015-02-12 08:12
- EMA: Metabolite(s) to demonstrate BE Helmut 2015-02-10 12:18
Ing. Helmut Schütz