Bioequivalence and Bioavailability Forum • Immediate release fixed dose combination product

Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2020-03-11 12:47 (1898 d 11:11 ago) – Posting: # 21240
Views: 6,201

Hello ping4santosh,
Even if you aim at substitution indication (improvement of patient's compliance) presenting co-prescription data and therapeutic guidelines recommending the co-administration will not suffice as long as you are unable to present clinical data demonstrating safety and efficacy of the respective combination. IMHO it will be hard to identify a new FDC which can be approved without a phase III study (at least in western Europe).

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Immediate release fixed dose combination product ping4santosh 2020-03-06 09:21 [Regulatives / Guidelines]
- Immediate release fixed dose combination product Ohlbe 2020-03-06 10:35
  - Immediate release fixed dose combination product ping4santosh 2020-03-09 11:50
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:22
      - Immediate release fixed dose combination product Ohlbe 2020-03-11 14:24
- Immediate release fixed dose combination product ElMaestro 2020-03-09 13:50
  - Immediate release fixed dose combination productDr_Dan 2020-03-11 11:47
    - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:21
      - Immediate release fixed dose combination product Dr_Dan 2020-03-11 13:44
        
        Immediate release fixed dose combination product ping4santosh 2020-03-11 14:22
        
        New product Ohlbe 2020-03-11 14:40
        
        New product ping4santosh 2020-03-11 16:34
        
        New product Ohlbe 2020-03-11 17:54
        
        New product ping4santosh 2020-03-11 20:52
  - Immediate release fixed dose combination product ping4santosh 2020-03-11 12:18