Bioequivalence and Bioavailability Forum • Reference Product

Reference Product [Regulatives / Guidelines]

posted by Tina – India, 2013-09-27 20:02 (4267 d 03:53 ago) – Posting: # 11570
Views: 5,851

Dear Helmut,

Thank you for the explanation.

For the product on which I am working currently, the innovator is not available in the EU. Only 2 generics are available. The generics would have got their MA based on their BE with the reference. Considering the non-availability of reference, is it justified to use one of the generics as comparator?

Complete thread:

Reference Product decision Tina 2013-04-22 11:40 [Regulatives / Guidelines]
- EEA: Reference Product Helmut 2013-04-22 13:09
  - Reference Product Tina 2013-09-24 14:08
    - Reference Product Helmut 2013-09-24 22:53
      - Reference ProductTina 2013-09-27 18:02
        
        Last time: R = innovator Helmut 2013-09-28 09:40
        Reference Product The Outlaw Torn 2013-09-30 08:18
        
        Reference Product Tina 2013-10-01 14:27
        
        Reference Product The Outlaw Torn 2013-10-02 08:03
        
        Reference Product Tina 2013-10-03 11:37