Bioequivalence and Bioavailability Forum

Rant… [Off Topic]

posted by luvblooms  – India, 2013-10-30 08:05 (4616 d 02:44 ago) – Posting: # 11811
Views: 8,865

Hi John

❝ One of my formulators asked "We have a single pt dissolution (IR) and failed f₂), what should we do? My reply "Who gives a crap, my bio passed BE!"

I struggle with my regulatory team almost daily on this f2 topics specially where para IV are of concern (mainly where formulation strategy based patents are important and we have done something totally opposite to come out of patent).


Life is tough!!!

Regards

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