Bioequivalence and Bioavailability Forum • Rant…

Rant… [Off Topic]

posted by jag009 – NJ, 2013-10-29 17:42 (4616 d 16:05 ago) – Posting: # 11806
Views: 8,889

Hi Helmut!

Yes #&%@! No I am not a consultant but I've gotten similar questions from other people too.

❝ Recently I received a question from an ASEAN-assessor which boiled down to:

“A generic product has demonstrated bioequivalence in a well-powered in vivo study. However, the formulation failed to show f₂ ≥50 in all p_H-values tested. Can I still accept the application?”

Are you serious?

John

Complete thread:

Rant… Helmut 2013-10-29 15:52
- Rant…jag009 2013-10-29 16:42
  - Rant… Helmut 2013-10-29 16:51
    - Rant… jag009 2013-10-29 20:23
      - Rant… Helmut 2013-10-29 21:09
        
        Rant… jag009 2013-10-30 15:03
        
        Rant… Helmut 2013-10-30 15:20
      - Rant… luvblooms 2013-10-30 07:05