Bioequivalence and Bioavailability Forum • Bioequivalence of racemic drugs using non-steriospecific bio

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

posted by scorp2011 – India, 2012-01-12 14:21 (4486 d 12:34 ago) – Posting: # 7914
Views: 7,846

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:

Bioequivalence of racemic drugs using non-steriospecific bioscorp2011 2012-01-12 13:21
- 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