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 jansari – India, 2022-05-27 20:54 (1484 d 01:45 ago) – Posting: # 23029
Views: 5,075

Dear divyen,

We have already gone through this PAR.bt the same it's just before published guidance..so regulatory not accept this PAR..

And it's very difficult to pass the study in this acceptance range..it's very stringent range for sevelamer carbonate..and guidance doesn't provide any methodology like USFDA..

If you have any idea and submit sevelamer study in europe Market then please guide....

Thank you very much for your prompt reply and guidance...

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