Bioequivalence and Bioavailability Forum

❝ […] if it is possible from a statistical point of view to use the same subjects participating in stage I also for stage II?

• Short answer: Not with the published methods. Here you would end up with a fully replicated design without scaling.
  
• Radio Yeravan’s answer: “In principle yes, but you have to take the repeated measurement charac­te­ris­tics into account and demonstrate that the TIE is maintained at ≤0.05.”
  Would be interesting to develop a suitable framework and get the adjusted α right. Since we don’t scale it should be doable. Whether it makes sense is yet another question. Study costs will be similar to conventional crossover TSDs (practically the same number of admin­is­tra­tions), but 2× higher blood loss, higher dropout rate, .