Bioequivalence of racemic drugs using non-steriospecific bio [Regulatives / Guidelines]
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
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:
- Bioequivalence of racemic drugs using non-steriospecific bioscorp2011 2012-01-12 13:21 [Regulatives / Guidelines]
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21
- BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
- BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
- BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
- BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
- BE of racemic drugs (EMA’s practice) Helmut 2019-12-30 14:35
- BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
- BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
- BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
- BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21