Bioequivalence and Bioavailability Forum • This monkey business

This monkey business [Power / Sample Size]

posted by jag009 – NJ, 2013-06-13 23:24 (4751 d 14:44 ago) – Posting: # 10782
Views: 14,344

Hi Helmut!

❝ ❝ n≥12 is what FDA wants.

❝

❝ Yes, for 2×2. Do you have a reference that 12 are enough for scaling?

A minimum number of 12 evaluable subjects should be included in any BE study. When an average BE approach is selected using either nonreplicated or replicated designs, methods appropriate to the study design should be used to estimate sample sizes.*

If I interpret this correctly then any design should have a min n=12, to finish. Okay, it's from the 2001 guidance and RSABE was introduced much later...

John

Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2001 BP

Complete thread:

This power business jag009 2013-06-13 16:49
- This monkey business Helmut 2013-06-13 17:40
  - This monkey business jag009 2013-06-13 19:57
    - This monkey business Helmut 2013-06-13 20:04
      - This monkey businessjag009 2013-06-13 21:24
        
        This monkey business Helmut 2013-06-13 21:33
        
        This monkey business jag009 2013-06-13 21:42
        
        This monkey business Helmut 2013-06-13 22:12
        
        This monkey business jag009 2013-06-13 23:06
        
        Minimum sample size for RSABE = 24 (enrolled) Helmut 2013-06-14 15:43
        
        Minimum sample size for RSABE = 24 (enrolled) jag009 2013-06-14 22:06
    - This monkey business ElMaestro 2013-06-14 01:57
      - This monkey business jag009 2013-06-14 20:49