Bioequivalence and Bioavailability Forum • Immediate release fixed dose combination product

Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh – India, 2020-03-11 15:22 (1504 d 09:16 ago) – Posting: # 21245
Views: 4,315

Dear Dr Dan,

Please accept my apology for spelling your name wrongly in my last draft.

Please allow me to ask you why you consider this as a new product? Both the APIs are registered as individual products in market and we are just combining both. Why would you call it as a new product that needs Efficacy and Safety data?

Thank you,
SKM

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 product Dr_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 productping4santosh 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