Bioequivalence and Bioavailability Forum • BE of racemic drugs (EMA’s practice)

BE of racemic drugs (EMA’s practice) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-12-30 15:35 (1946 d 03:58 ago) – Posting: # 21038
Views: 3,451

Hi Valiveti,

❝ Please update us the status of your query. same query was received from agency.

Are you aware that you are replying to an almost eight years old post? Looking at the profile of scorp2011 you would have discovered that he/she logged in for the last time 4½ years ago. An answer is unlikely.

Which agency? See this post (linked others within and followings). In none of the EMA’s product-specific guidances an enantiomeric separation is recommended. Are you a victim of the “backdoor”? More details, please.

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Helmut Schütz

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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