Bioequivalence and Bioavailability Forum • FDC with ascorbic acid

FDC with ascorbic acid [Regulatives / Guidelines]

posted by qualityassurance – 2024-07-23 12:13 (291 d 15:55 ago) – Posting: # 24089
Views: 2,571

Dear Ohlbe,

❝ I am not sure that I fully understand what you are trying to achieve here.

We want to register anti cold product combining with ascorbic acid. FDC of anticold is already registered however FDC of anti cold with ascorbic acid is not registerd in EU.

❝ If ascorbic acid is indeed only used as excipient (e.g. as antioxidant).

Actually ascorbic acid in our formulation will have therapeutic effect. In this case only BE is suffice or safety and efficacy is needed in patients?

❝ Difficult to say which without knowing what your two active ingredients are

It is very known molecule used in cold and flu.

Regards,
QA

Complete thread:

FDC with ascorbic acid qualityassurance 2024-07-23 08:08 [Regulatives / Guidelines]
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
  - FDC with ascorbic acidqualityassurance 2024-07-23 10:13
    - Placebo? Helmut 2024-07-23 12:39
      - Placebo? mittyri 2024-07-23 14:54
        
        🇦🇹 AGES Helmut 2024-07-24 11:16
      - Placebo? qualityassurance 2024-07-24 11:37
        
        Sorry – wrong addressee Helmut 2024-07-24 13:31
        
        lucky mittyri 2024-07-24 16:01