Bioequivalence and Bioavailability Forum • Sample Size

Sample Size [Power / Sample Size]

posted by Dr_Dan – Germany, 2013-09-04 11:52 (4308 d 16:53 ago) – Posting: # 11427
Views: 8,170

Dear Anu,
I am not sure if you really know what you are talking about

❝ A crossover study with 21 subjects.

there you have a sample size

❝ Bioequivalence assessment using pharmacodynamics:

what kind of parameter? AUEC, Cmax?

❝ 1. Test-Reference= -0.69

ratio?

❝ 2. 90 % CI = -1.07 to -0.30 which is in the limit of ( -20 to 20) %

In bioequivalence testing the 90% confidence interval for the exponential of the difference in LSmeans between the Test and Reference product are calculated for the ln transformed parameters. The data you present do not fit.

Please reassess your question, maybe it would be helpful to provide more information and before you ask the same question a third time please ensure that you have the necessary basic understanding of bioequivalence assessment. Have a look into Helmut's lectures!
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Sample Size Anu 2013-09-04 07:03 [Power / Sample Size]
- Sample SizeDr_Dan 2013-09-04 09:52
- Linear model and Fieller… Helmut 2013-09-04 13:20
  - Linear model and Fieller… jag009 2013-09-04 17:23
    - Linear model and Fieller… Anu 2013-10-04 13:16
      - Linear model and 80–120% Helmut 2013-10-04 15:20
        
        Linear model and 80–120% Anu 2013-10-07 09:59
        
        CVintra < CVtotal? Helmut 2013-10-07 14:14