Sevelamer Carbonate In vitro binding study for EMA submission [Regulatives / Guidelines]

posted by jansari – India, 2022-05-26 19:59 (80 d 13:41 ago) – Posting: # 23025
Views: 255

Dear divyen,

Thank you very much for providing this supporting documents to justify the this PAR published in the year 2014 and my concern is that whether we have to justify the response with this reference docs?

As EU release one guidance documents for locally acting drug in GI tract in oct 2018.this guidance is not as much clear as us fda guidance..

but in this guidance on page no. 10 stated that in vitro similarity should be assessed with +-10%acceptance similarity should be proven based on T/R ratio or 90%CI needs to b calculate?

Reference doc's attached with this post..

Kindly guide on this...

Thnk you in advance.....

Edit: Send by email to the forum address. @Jansari: Reply directly in the forum in the future. THX. [Helmut]

Complete thread:

UA Flag
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Monday 09:41 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

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