Bioequivalence and Bioavailability Forum

Highly Variable Drug BE Justification [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-03-20 05:55  - Posting: # 17167
Views: 2,123

Hi jag009,

» What if one conducted pilot studies and found that the ISCV is like 28/29%? My concensus still would be to proceed with RSABE approach since the it is a mixed approach which allows both RSABE(if Ref SD<0.294) and ABE analysis(if Ref SD>0.294)

That's valid, but if you are not really sure if you are just "borderline" then the additional overhead associated with the replicated design may not be worth it. You find an intra-CV_R of 31%, and you scale the limits a wee bit etc. But the price you paid for this moderate scaling option could be much higher than you'd be paying for a conventional 222BE trial with a few extra volunteers. Would be interesting to discuss an objective function here

This isn' the answer, but just a view.

Complete thread:

• Highly Variable Drug BE Justification - jag009, 2017-03-20 04:42 [Regulatives / Guidelines] 
  • Highly Variable Drug BE Justification - ElMaestro, 2017-03-20 06:55
    • Study costs: Replicate vs. 2×2×2 - Helmut, 2017-03-20 13:12
      • Study costs: Replicate seems to be cheaper - VStus, 2017-03-21 12:49
        • Study costs: Replicate seems to be cheaper - Dr_Dan, 2017-03-21 13:06
          • Study costs: Replicate seems to be cheaper - Helmut, 2017-03-21 14:50
            • expected power - d_labes, 2017-03-21 15:16
            • Doesn't hurt! - VStus, 2017-03-23 14:24
      • Study costs: Replicate vs. 2×2×2 - mahmoud-teaima, 2017-03-23 08:17
      • Study costs: Replicate vs. 2×2×2 - M.tareq, 2017-05-07 21:21
        • Replicate vs. 2×2×2 (ethics?) - Helmut, 2017-05-08 14:21
          • Replicate vs. 2×2×2 (ethics?) - nobody, 2017-05-08 14:52
            • Applicability of reference-scaling - Helmut, 2017-05-10 14:10
          • Replicate vs. 2×2×2 - M.tareq, 2017-05-14 23:04
            • Replicate vs. 2×2×2 - Helmut, 2017-05-15 19:07
              • Replicate vs. 2×2×2 - M.tareq, 2017-05-15 21:02
              • Regulators view of HVD drugs - DavidManteigas, 2017-05-16 12:41
                • Regulators view of HVD drugs - Helmut, 2017-05-16 15:01
                • What's the problem? - ElMaestro, 2017-05-17 03:30
                  • What's the problem? - nobody, 2017-05-17 07:48
                    • What's the problem? - nobody, 2017-05-17 09:31
                      • What's the problem? - DavidManteigas, 2017-05-17 11:25
                        • What's the problem? - ElMaestro, 2017-05-17 12:07