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

posted by scorp2011 – India, 2012-01-12 12:21  – Posting: # 7914
Views: 4,948

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:

Activity
 Admin contact
20,242 posts in 4,259 threads, 1,395 registered users;
online 13 (0 registered, 13 guests [including 9 identified bots]).
Forum time (Europe/Vienna): 03:26 UTC

Not to be absolutely certain is, I think,
one of the essential things in rationality.    Bertrand Russell

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