Bioequivalence and Bioavailability Forum

Parallel study as pilot for long half life drug [Design Issues]

posted by d_labes  – Berlin, Germany, 2012-05-07 18:24 (5148 d 08:14 ago) – Posting: # 8526
Views: 5,711

Dear Dan!

❝ ... The CV% you get from the pilot is the total CV%, right. You use this to calculate your sample size for the pivotal study but it does not predetermine the design of the pivotal study.

Totally Can you please elaborate what this means?

Complete thread:

• Parallel study as pilot for long half life drug jag009 2012-05-07 15:13 [Design Issues] 
  • Parallel study as pilot for long half life drug Dr_Dan 2012-05-07 16:00
    • Parallel study as pilot for long half life drugd_labes 2012-05-07 16:24
    • Parallel study as pilot for long half life drug jag009 2012-05-07 18:15
      • AUC72 Helmut 2012-05-07 19:31
        • AUC72 jag009 2012-05-07 20:15
          • AUC72 Dr_Dan 2012-05-08 12:17
            • AUC72 jag009 2012-05-10 15:15
              • AUC72: NDAs Helmut 2012-05-10 15:56
                • AUC72: NDAs jag009 2012-05-14 15:22