Bioequivalence and Bioavailability Forum

BE demonstrated in pilot study [Power / Sample Size]

posted by H_Rotter – Germany, 2006-05-20 15:56 (7325 d 23:14 ago) – Posting: # 132
Views: 21,963

Hi Joy,

at least for the USA it should be possible to show BE in a pilot study, because http://www.fda.gov/cder/guidance/5356fnl.pdf FDA states at
III.A.2. Pilot study:
“[…] A pilot study that documents BE can be appropriate, provided its design and execution are suitable and a sufficient number of subjects (e.g., 12) have completed the study.”

But don’t ask me, what ‘sufficient number’ actually means.

Best regards,
Hermann

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Edit: Link corrected to latest archived copy. [Helmut]

Complete thread:

• Sample size for a pilot BE joyjac 2006-05-18 08:13 [Power / Sample Size] 
  • Confidence Interval for CV Helmut 2006-05-18 13:17
    • One-sided Confidence Limit for CV Helmut 2006-05-18 14:36
      • One-sided Confidence Limit for CV joyjac 2006-05-19 01:22
        • One-sided Confidence Limit for CV Helmut 2006-05-19 13:02
        • BE demonstrated in pilot studyH_Rotter 2006-05-20 13:56
    • Confidence Interval for CV intuitivepharma 2013-05-06 12:31
      • use PowerTOST Helmut 2013-05-06 13:09
        • use PowerTOST intuitivepharma 2013-05-07 08:52