Bioequivalence and Bioavailability Forum • BE of racemic drugs (EMA vs. FDA)

BE of racemic drugs (EMA vs. FDA) [Regulatives / Guidelines]

posted by scorp2011 – India, 2012-01-13 07:11 (4479 d 10:49 ago) – Posting: # 7922
Views: 6,298
(edited by Jaime_R on 2012-01-13 09:43)

Dear HS,
Thanks for the detailed information.
I have a question. A BE study of racemic drug was conducted for EU submission and the bioequivalence was concluded based on the measurement of racemic drug. In the study enantiomers were not measured. The BE study was approved by the several EU regulatory authority. Now one of the EU regulatory body has asked to justify why enantiomers were not measured and why BE was concluded on racemic compound???

Please help in getting out of this situation.

Regards
scorp

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]

Complete thread:

Bioequivalence of racemic drugs using non-steriospecific bio scorp2011 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