Bioequivalence and Bioavailability Forum

NTIDs with high variability [Design Issues]

posted by ioanam – Romania, 2010-06-07 15:52 (5868 d 10:11 ago) – Posting: # 5452
Views: 12,184

Which is the most appropriate design for a narrow therapeutic index drug with very high intra-subject variability?

For example, we have an immunosuppressive agent with an intra-subject CV% > 45%.
Using a standard two – way crossover design with acceptance interval tightened (90.00 – 111.11%), we will have a sample size of more than 300 subjects .

It is possible to use a replicate design in this situation?

Thank you,
Jo

Complete thread:

• NTIDs with high variabilityioanam 2010-06-07 13:52 [Design Issues] 
  • NTIDs # HVDs (or not?) Helmut 2010-06-07 14:18
    • NTIDs # HVDs (or not?) ioanam 2010-06-07 18:17
      • Complicated ElMaestro 2010-06-07 18:28
    • NTIDs # HVDs (or not?) Dr_Dan 2010-06-08 12:24
      • Switch over Helmut 2010-06-08 12:34
        • NTIDs # HVDs (or not?) Relaxation 2010-06-09 22:38
          • FDA scaling for NTIDs krishna 2013-01-07 14:01
            • FDA scaling for NTIDs Helmut 2013-01-12 20:06
              • FDA scaling for NTIDs krishna 2013-01-18 10:04
                • FDA scaling for NTIDs Helmut 2013-01-20 12:46
                  • FDA scaling for NTIDs krishna 2013-02-01 12:20