Bioequivalence and Bioavailability Forum

calculation of 90% CI for continuous variable in clinical endpoint studies [General Sta­tis­tics]

posted by DavidManteigas – Portugal, 2017-11-21 11:01 (2024 d 23:42 ago) – Posting: # 17996
Views: 4,440

Hi GM,

As El Maestro explained, when your test hypothesis is a ratio (multiplicative model) then you must work with ln transformed data. The guidance is clear on that as it also defines the acceptance range as 0.8 to 1.25 (multiplicative model). If in some guideline they state the hypothesis as treatment differences (H0: u1-u2=0) and a symmetric equivalence range (0.8 to 1.2) then they would be suggesting an analysis on untransformed data. This is true regardless of the type of your endpoint as long as it is a continuous endpoint. As simple as that

Regards,
David

Complete thread:

• calculation of 90% CI for continuous variable in clinical endpoint studies GM 2017-11-17 04:55 [General Sta­tis­tics] 
  • calculation of 90% CI for continuous variable in clinical endpoint studies ElMaestro 2017-11-18 21:17
    • calculation of 90% CI for continuous variable in clinical endpoint studies GM 2017-11-19 12:13
      • calculation of 90% CI for continuous variable in clinical endpoint studies ElMaestro 2017-11-20 20:41
        • calculation of 90% CI for continuous variable in clinical endpoint studies GM 2017-11-21 06:02
          • calculation of 90% CI for continuous variable in clinical endpoint studiesDavidManteigas 2017-11-21 10:01