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

posted by scorp2011 – India, 2012-01-12 13:21  – Posting: # 7914
Views: 5,584

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.


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