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

posted by jansari  – India, 2023-02-21 18:28 (874 d 14:18 ago) – Posting: # 23469
Views: 4,678

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
23,436 posts in 4,932 threads, 1,677 registered users;
51 visitors (0 registered, 51 guests [including 13 identified bots]).
Forum time: 09:46 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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