Bioequivalence and Bioavailability Forum • Sample size for a pilot BE

Sample size for a pilot BE [Power / Sample Size]

posted by joyjac – Philippines, 2006-05-18 10:13 (7328 d 03:57 ago) – Posting: # 125
Views: 26,545

Before proceeding with a full-scale BE, we do pilot or trial study to validate the bioanalytical method and optimize sampling time intervals. We would also want to assess the variability i.e. intra-subject that would help us determine the best sample size for the full-scale BE.

Can anyone suggest what should be the sample size for a pilot BE to obtain the above objectives. Thanks.

Complete thread:

Sample size for a pilot BEjoyjac 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 study H_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