Bioequivalence and Bioavailability Forum

Sample Size BA/BE [Power / Sample Size]

posted by Helmut  – Vienna, Austria, 2010-03-01 15:00 (5946 d 04:20 ago) – Posting: # 4840
Views: 16,545

Dear SriKanth!

❝ If we don't have information regarding the variability of the treatments, how do we estimate the sample size?

Get the CV_intra from a pilot study.

❝ While estimating the sample size, for BE studies we use 90% CI limits as per guidance, but for BA studies what should be the 90% CI limits […]

No; in BA report 95 % CI. For sample sizes in BA, see this post.

❝ […] and how it will be decided?

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


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Science Quotes

Complete thread:

• Sample Size BA/BE Sriraj 2010-02-26 14:32 [Power / Sample Size] 
  • Sample Size BA/BEHelmut 2010-03-01 14:00
    • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 19:25
      • Sample size for a pilot study to estimate the CVintra Helmut 2010-03-01 21:01
        • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 23:47
          • Sample size for a pilot study to estimate the CVintra Helmut 2010-03-03 19:04
            • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-04 22:35
        • 80% confidence ? d_labes 2010-03-19 13:02
          • 75% confidence... Helmut 2010-03-19 14:12
      • Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-01 22:23
        • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-02 00:02
        • Sample size for a pilot study to estimate the CVintra Helmut 2010-03-02 02:19
          • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:27
            • Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-29 13:39
              • Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:47
            • Sequential designs (history and future) Helmut 2010-03-29 14:19
              • Sequential designs (history and future) yjlee168 2010-03-29 19:19
                • Sequential designs (history and future) Helmut 2010-03-29 20:43
                  • Sequential designs (history and future) yjlee168 2010-04-01 18:58
                    • Sequential designs (WinNonlin vs. bear) Helmut 2010-04-02 21:00