Bioequivalence and Bioavailability Forum • Minimum sample size for RSABE = 24 (enrolled)

Minimum sample size for RSABE = 24 (enrolled) [Power / Sample Size]

posted by jag009 – NJ, 2013-06-15 00:06 (4762 d 07:13 ago) – Posting: # 10800
Views: 14,183

Hi Helmut,

❝ • At least 24 subjects should be enrolled

❝ • Reference replicate data analyzed for determination of σ_wr

❝ • If σ_wr < σ_w0 then data analyzed using unscaled average BE method

❝ • If σ_wr ≥ σ_w0 then data analyzed using scaled average BE and point-estimate criteria

❝ (my emphasis)

❝ Fascinating: Scaled BE limits given on slide 20. ;-)

❝

❝ Also interesting that in none of the API-specific guidances (first one progesterone, April 2010) a minimum sample size is mentioned.

"24 should be enrolled", so they want us to start with 24 but not necessary finish with 24. This # concur with Endrenyi et al's sample size article of n=24 at CV=30% with Ratio = 0.95 or 1.05 → 80% power.

Thanks
John

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 business jag009 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