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RegisterIs a Chiral method required? [Regulatives / Guidelines]
A Clinical study is going to be with an enantiomer (not racemate).
The enantiomers exhibit different pharmacodynamic characteristics but only the active enantiomer is going to be in the formulation.
There is no in-vivo interconversion.
The reference standard is going to be the enantiomer (not racemate).
Is a chiral method required? Can I go with a simple achiral method?
Edit: Please follow the Forum’s Policy. [Helmut]
The enantiomers exhibit different pharmacodynamic characteristics but only the active enantiomer is going to be in the formulation.
There is no in-vivo interconversion.
The reference standard is going to be the enantiomer (not racemate).
Is a chiral method required? Can I go with a simple achiral method?
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- Is a Chiral method required?xtianbadillo 2018-01-16 16:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Racemate vs. enantiomer? Helmut 2018-01-17 14:40
- Racemate vs. enantiomer? xtianbadillo 2018-01-17 19:31
- Racemate vs. enantiomer? Relaxation 2018-01-18 10:37
- Racemate vs. enantiomer? Helmut 2018-01-18 10:55
- Racemate vs. enantiomer? Helmut 2018-01-17 14:40
Ing. Helmut Schütz