Bioequivalence and Bioavailability Forum

What if I run a study with 2 references? [Design Issues]

posted by jag009  – NJ, 2012-06-12 22:00 (4757 d 15:48 ago) – Posting: # 8720
Views: 9,812

Just out of curiosity, no I am not happy substances..

Would any reg agency accept a bioequivalence study involving 1 Test and 2 reference (meaning 2 difference lot numbers) and claim bioequivalence when the test shows BE to only one lot of reference?
Someone from the my lab asked this question. I really thought he was

John

Complete thread:

• Curiosity: Running BE studies with more than 2 arms jag009 2012-06-11 15:01 [Design Issues] 
  • Common variance! Helmut 2012-06-11 16:23
    • Common variance! jag009 2012-06-11 17:25
      • Common variance! Helmut 2012-06-11 17:35
        • Common variance! jag009 2012-06-11 20:03
          • Common variance! ElMaestro 2012-06-11 20:34
            • Common variance! Helmut 2012-06-12 01:03
              • Common variance! ElMaestro 2012-06-12 13:22
    • Common variance! jag009 2012-06-12 19:56
      • What if I run a study with 2 references?jag009 2012-06-12 20:00
      • Common variance! Helmut 2012-06-12 20:39
        • Two References d_labes 2012-06-13 09:11
          • Two References jag009 2012-09-10 22:48
            • Two treatments only d_labes 2012-09-11 08:20
    • Common variance! jag009 2012-06-13 16:08