Bioequivalence and Bioavailability Forum • Expected deviation in sample size estimation

Expected deviation in sample size estimation [Power / Sample Size]

posted by Karmegams – India, 2011-06-13 08:05 (5485 d 03:20 ago) – Posting: # 7110
Views: 6,765

Dear Sir,

Thank you very much for your clarification.

The reason for my doubt (Normally we use Expected deviation of 5% or 7.5% in sample size calculation for bioequivalence study. please suggest me the maximum Expected deviation that can be used for sample size calculation?) is:
In two cross over design; for 90% CI, a sample size of "40 subjects" it gives 80% power if product having CV-intra of 25% and their expected deviation is assumed as 7.5%.

For 90% CI, a sample size of "40 subjects" is gives >90% power if product having CV-intra of 25% and their expected deviation is assumed as 5%.

Regards,
Skar

Complete thread:

Expected deviation in sample size calculation Karmegams 2011-06-10 07:54
- Expected deviation in sample size calculation Dr_Dan 2011-06-10 08:51
  - Expected deviation in sample size calculation Karmegams 2011-06-10 09:57
- Expected deviation in sample size calculation ElMaestro 2011-06-10 12:19
  - Expected deviation in sample size estimation Helmut 2011-06-10 13:40
    - Expected deviation in sample size estimation Dr_Dan 2011-06-10 15:06
    - Expected deviation in sample size estimationKarmegams 2011-06-13 06:05
      - Expected deviation in sample size estimation GSTATS 2011-06-13 07:36