Bioequivalence and Bioavailability Forum

RSABE (EU) [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2010-01-07 10:14 (6004 d 21:58 ago) – Posting: # 4569
Views: 5,766

Dear Helmut,

❝ It's important that you power your study to show BE for the case that

❝ CV<30%. Example: expected CV 40%, expected T/R 95%, power 80%,

❝ n for a partial replicate design with 75%-133% = 36;

❝ if CV in the study = 29 (no widening; AR 80%-125% applicable), T/R 95.5%.

Where does the sample size for the partial replicate design come from?

Complete thread:

• Scaled Average Bioequivalence graveendranath 2010-01-06 07:36 [Regulatives / Guidelines] 
  • RSABE (EU) Helmut 2010-01-06 17:01
    • RSABE (EU)d_labes 2010-01-07 09:14
      • RSABE (EU) Helmut 2010-01-07 13:21
        • Sample size partial replicate design d_labes 2010-01-07 13:56
          • Sample size partial replicate design Helmut 2010-01-07 14:23
            • Sample size partial replicate design: df d_labes 2010-01-07 16:21
            • Sample size partial replicate design: variance d_labes 2010-01-08 10:37