Bioequivalence of racemic drugs using non-steriospecific bio [Regulatives / Guidelines]

posted by scorp2011 – India, 2012-01-12 14:21 (4459 d 23:01 ago) – Posting: # 7914
Views: 7,744

Dear ALL,
My question is related to the bioequivalence requirements of chiral drugs.
How to substantiate the use of achiral bio-analysis for racemic drugs with enantiomers having differing pharmacokinetics. Please also comments on the recommendations on the use of chiral/achiral methods as presented in the current Bioequivalence guideline (CPMP/QWP/EWP/1401/98 Rev.1).

Thanks in anticipation.

Regards
scorp

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
103 visitors (0 registered, 103 guests [including 9 identified bots]).
Forum time: 13:22 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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