In vitro binding study for sevelamer carbonate for Europe submission [Regulatives / Guidelines]

posted by jansari  – India, 2023-02-21 18:28 (400 d 21:38 ago) – Posting: # 23469
Views: 2,269

Dear All,


Is there any specific guidance documents for in vitro binding study for sevelamer carbonate for EU submission?
Is there any acceptance limit for Sevelamer carbonate product for EMA submission?

A response will be highly appreciated.

Thanks in advance for your help.

Regards,
Jansari

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
83 visitors (0 registered, 83 guests [including 11 identified bots]).
Forum time: 16:07 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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