Bioequivalence and Bioavailability Forum

Which “target regulation”? [Regulatives / Guidelines]

posted by nobody – 2016-04-27 11:15 (3093 d 00:31 ago) – Posting: # 16245
Views: 7,297

❝ Fascinating that an increase of AUC by ~80% was judged Down Under to be not substantial…

It's originator, stupid! Things are somewhat different in the non-generic world.

Complete thread:

• Bioequivalence study of Sofosbuvir Dr Naghma Hashmi 2016-03-18 12:34 [Regulatives / Guidelines] 
  • Which “target regulation”? Helmut 2016-03-18 14:23
    • Bioequivalence study of Sofosbuvir Dr Naghma Hashmi 2016-03-19 10:59
      • No “WHO regulation”! Helmut 2016-03-19 18:03
        • No “WHO regulation”! Dr Naghma Hashmi 2016-03-22 04:51
          • Science ≠ truth ∧ regulations ≠ science Helmut 2016-03-22 14:06
    • Which “target regulation”?nobody 2016-04-27 09:15