Is a Chiral method required? [Regulatives / Guidelines]

posted by xtianbadillo – Mexico, 2018-01-16 17:02 (3072 d 06:19 ago) – Posting: # 18185
Views: 5,441

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
129 visitors (0 registered, 129 guests [including 24 identified bots]).
Forum time: 00:22 CEST (Europe/Vienna)

The idea is to try and give all the information to help others
to judge the value of your contribution;
not just the information that leads to judgment
in one particular direction or another.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5