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

posted by scorp2011 – India, 2012-01-13 06:11 (3486 d 14:51 ago) – Posting: # 7922
Views: 5,454

(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.


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]

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