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, 2022-05-27 20:40 (1082 d 06:23 ago) – Posting: # 23028
Views: 3,101

Dear janasari!
The link of PAR (Approved just before the Oct'18) is provided where the acceptance range is 80-120%. From guideline perspective, the 10% usually can be considered as CI.
Regards,
Divyen

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 submission dshah 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 submissiondshah 2022-05-27 18:40
      - Sevelamer Carbonate In vitro binding study for EMA submission jansari 2022-05-27 18:54