Bioequivalence and Bioavailability Forum • Reference Product

Reference Product [Regulatives / Guidelines]

posted by Tina – India, 2013-09-24 16:08 (4270 d 07:51 ago) – Posting: # 11551
Views: 6,004

Dear Helmut,

Thank you for the clarification.

Instead of MRP/DCP, if the product were to be marketed only in one country and if the innovator isnt available in that country, are we justified in showing BE with the generic which is available in the country (which has showed BE with the innovator?) and is available in the market for more than 8 years.

If the innovator product is a capsule and the proposed test are tablets and if innovator in not available in the proposed country, doing a BE study in the existing generic (tablets ) will reduce formulation (capsule vs tablet) associated any change in the release of the active from the formulation.

I look forward to your reply

Complete thread:

Reference Product decision Tina 2013-04-22 11:40 [Regulatives / Guidelines]
- EEA: Reference Product Helmut 2013-04-22 13:09
  - Reference ProductTina 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 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