Bioequivalence and Bioavailability Forum

Failing BE study due to AUCinf [NCA / SHAM]

posted by jag009  – NJ, 2013-06-19 21:41 (3963 d 00:37 ago) – Posting: # 10828
Views: 6,898

Hi ElMaestro,

Fortunately I haven't encountered such problem yet but I have seen drugs with crazy AUCinfinity being reported ⇒ like T1/2 = 5000 hrs (the individual values should sig degree of variability but 5000 hrs is a bit ridiculous, if not BS)

Granted that it was a pilot study so I ended up playing with the data...

Thanks
John

Complete thread:

• Failing BE study due to AUCinf jag009 2013-06-19 17:44 
  • AUC∞ = lousy metric Helmut 2013-06-19 18:15
    • AUC∞ = lousy metric jag009 2013-06-19 19:35
    • AUC∞ = lousy metric jag009 2013-06-19 21:20
      • AUC∞ = lousy metric Helmut 2013-06-20 17:29
        • AUC∞ = lousy metric jag009 2013-06-20 20:32
  • Failing BE study due to AUCinf ElMaestro 2013-06-19 18:48
    • Failing BE study due to AUCinfjag009 2013-06-19 19:41
      • BS Helmut 2013-06-20 17:59
        • BS jag009 2013-06-20 20:35