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

posted by Helmut Homepage – Vienna, Austria, 2019-12-30 14:35 2a02:8388:6bc2:ce80:ecf1:7da1:2052:4299 – Posting: # 21038
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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.

Cheers,
Helmut Schütz
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