Bioequivalence and Bioavailability Forum • Sample size calculation based on T/R ratio

Sample size calculation based on T/R ratio [Power / Sample Size]

posted by Tina – India, 2014-05-16 13:38 (4418 d 09:10 ago) – Posting: # 12955
Views: 8,429

Dear all,

I have a very basic question in statistics.

Why is the sample size different if we were to calculate on assuming (95 to 105) vs 90 to 110? Why is (90 to 110) higher than calculating sample size for (95 to 105)?

Ideally to have an allowance of 10 should have higher sample size than to have an allowance of 20.
(95 to 105) vs (90 to 110)—Which assumption (for calculating sample size) is preferred by the regulators
If regulators are fine with both, can we not take the option of (95 to 105) as it helps with lesser costs due to lesser sample size

Kind regards,
Tina

Edit: Category changed. [Helmut]