Bioequivalence and Bioavailability Forum • C of A

C of A [GxP / QC / QA]

posted by Ohlbe – France, 2011-02-21 20:09 (5600 d 12:28 ago) – Posting: # 6655
Views: 8,934

Dear Dan,

If the drug was sampled from the local market, there is indeed no real problem. I'm more concerned about a product sampled from a foreign market. Think how the BfArM would react if you intended to run a study in Germany with a non-EU product, without a release by a QP. But it may actually be a regulatory issue as much as an ethical question.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

C of A M.Vasu 2011-02-10 14:14
- C of A Ohlbe 2011-02-10 16:01
  - C of A M.Vasu 2011-02-10 16:18
    - C of A Ohlbe 2011-02-10 22:31
      - C of A Dr_Dan 2011-02-16 11:00
        
        C of A M.Vasu 2011-02-17 04:24
        
        C of A Dr_Dan 2011-02-17 10:26
        
        C of AOhlbe 2011-02-21 19:09
        
        C of A Dr_Dan 2011-02-22 09:42