Bioequivalence and Bioavailability Forum • RSABE (EU)

RSABE (EU) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-01-07 14:21 (6006 d 16:26 ago) – Posting: # 4571
Views: 6,082

Dear D. Labes!

❝ ❝ 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?

❝ :ponder:

Oops! I've set power to 90% instead of 80%. Sorry.
So with CV 40%, 3-way replicate, 75%-133%: n=30; and with n=30, CV 29%, replicate, 80%-125%: T/R 94.4%.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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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