Is a Chiral method required? [Regulatives / Guidelines]

posted by xtianbadillo – Mexico, 2018-01-16 17:02 (2381 d 08:33 ago) – Posting: # 18185
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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?


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