Bioequivalence and Bioavailability Forum • In vitro binding study for sevelamer carbonate for Europe submission

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

posted by jansari – India, 2023-02-21 18:28 (223 d 23:18 ago) – Posting: # 23469
Views: 1,725

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:

In vitro binding study for sevelamer carbonate for Europe submissionjansari 2023-02-21 17:28
- In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-22 16:40
  - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-23 16:22
    - In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-23 17:18
      - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-24 15:24
        
        In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-28 17:15
        
        In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-03-01 15:34