Bioequivalence and Bioavailability Forum • Sevelamer Carbonate In vitro binding study for EMA submission

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

posted by dshah – India/United Kingdom, 2022-05-26 15:28 (693 d 13:51 ago) – Posting: # 23022
Views: 1,501

Dear Jansari!

In-vitro phosphate binding studies are acceptable for Sevelamer Carbonate. PAR and 2 information can be found for same. The acceptance range was 80-125% in PAR.
Regards,
Divyen Shah

Complete thread:

Sevelamer Carbonate In vitro binding study for EMA submission jansari 2021-09-24 19:03
- Sevelamer Carbonate In vitro binding study for EMA submission jansari 2022-05-19 20:02
- Sevelamer Carbonate In vitro binding study for EMA submissiondshah 2022-05-26 13:28
  - Sevelamer Carbonate In vitro binding study for EMA submission jansari 2022-05-26 19:59
    - Sevelamer Carbonate In vitro binding study for EMA submission dshah 2022-05-27 18:40
      - Sevelamer Carbonate In vitro binding study for EMA submission jansari 2022-05-27 18:54