Bioequivalence and Bioavailability Forum

Stati­stical sig­ni­fi­cance of lab para­meters in BE-studies [General Sta­tis­tics]

posted by BE-proff – 2015-12-20 19:57 (3840 d 09:01 ago) – Posting: # 15749
Views: 8,670

Hi All,

In most Russian BE-studies lab parameters are assessed twice - at the screening and at the end of study.
Then obtained results are compared to each other statistically (depending on type of distribution) and conclusion about statistical significance of changes is done.

Is it worth doing?

I have some doubts because sample size is calculated to show BE of medications.

Complete thread:

• Stati­stical sig­ni­fi­cance of lab para­meters in BE-studiesBE-proff 2015-12-20 18:57 
  • Nil Helmut 2015-12-20 19:16
    • Nil BE-proff 2015-12-20 20:16
      • lab tests at least twice mittyri 2015-12-21 00:24
        • Be creative! (#2) Helmut 2015-12-21 01:09
          • Creative Russian experts mittyri 2015-12-21 01:40