Bioequivalence and Bioavailability Forum • Reference Product

Reference Product [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-09-30 10:18 (4264 d 13:46 ago) – Posting: # 11576
Views: 5,867
(edited on 2013-09-30 13:01)

Dear Tina,

I think you are indeed out of luck.

I see two potential options.

First, if you can find a reference product in another non-EU market and can provide evidence that it was based on the same global development that the European reference was based on when it was avaiable, then you can try to compare against this non-EU sourced reference product.

Second, the only other option I see is going the well-established use route. However, well-established use applications apparently now require a BE study (as per scientific advice). Yes, it doesn't make sense, but...

As you can see, both options appear to be long shots. But good luck nonetheless.

Outlaw Torn

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 Product Tina 2013-09-27 18:02
        
        Last time: R = innovator Helmut 2013-09-28 09:40
        Reference ProductThe 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