Bioequivalence and Bioavailability Forum • FDC with ascorbic acid

FDC with ascorbic acid [Regulatives / Guidelines]

posted by qualityassurance – 2024-07-23 10:08 (348 d 19:45 ago) – Posting: # 24087
Views: 4,019

Dear Forum members,

In case FDC (two active ingredients) with ascorbic acid is not approved in Europe. However, FDC (two active ingredients) is approved. In case if we want to apply for FDC (two active ingredients) with ascorbic acid in Europe, is it needed to conduct any safety and efficacy study in patients or only BE study will be enough justifying that ascorbic acid is used as an excipient?

Regards,
QA

Complete thread:

FDC with ascorbic acidqualityassurance 2024-07-23 08:08 [Regulatives / Guidelines]
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
  - FDC with ascorbic acid qualityassurance 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