Bioequivalence and Bioavailability Forum

drugs of long half life [Design Issues]

posted by jag009  – NJ, 2013-04-02 17:17 (4408 d 10:58 ago) – Posting: # 10327
Views: 7,806

Hi Ken,

I once ran 2 2-way crossover studies with a 90 day washout (management didn't want to take a chance with a parallel study design). The studies were okay, we had 5-10 dropouts.

The sample size for parallel design (I think Helmut mentioned this to me before, right Helmut? ) is based on the total CV (intersubject CV and intrasubject CV).

90% CI computation will be done using the intersubject CV¹

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1. Niazi, SK. Handbook of Bioequivalence Testing. Drugs and Pharmaceutical Sciences, Vol 171, p28.

Complete thread:

• drugs of long half life Ken Peh 2013-03-31 06:43 [Design Issues] 
  • drugs of long half lifejag009 2013-04-02 15:17
    • drugs of long half life Helmut 2013-04-02 15:34
      • drugs of long half life jag009 2013-04-02 16:01
        • drugs of long half life Helmut 2013-04-02 16:40
          • parallel FDA d_labes 2013-04-04 08:33
            • parallel FDA jag009 2013-04-05 18:01
            • parallel FDA jag009 2013-04-05 21:10
              • random repeated parallel FDA d_labes 2013-04-08 08:29
                • Proc Mixed: random repeated parallel FDA jag009 2013-04-08 15:36
                  • Proc Mixed: parallel groups with different variabilities d_labes 2013-04-08 16:41
                    • Proc Mixed: parallel groups with different variabilities jag009 2013-04-08 20:22
    • drugs of long half life Ken Peh 2013-04-04 15:03
      • drugs of long half life jag009 2013-04-05 17:45