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

posted by Helmut Homepage – Vienna, Austria, 2019-12-30 14:35 (386 d 07:10 ago) – Posting: # 21038
Views: 1,439

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.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,306 posts in 4,443 threads, 1,488 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Tuesday 21:46 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5