Bioequivalence and Bioavailability Forum

Hello Pandu,

❝ Generally in BA/BE studies we using ANOVA (Proc GLM or Proc Mixed) for statistical evaluations. Pls let me know where we can use the ANCOVA and when it can apply? Is there any agency required for statistical analysis with ANCOVA?

Introduction of covariates in statistical models isn't common in bioequivalence. I am not aware of any agency requiring it for PK comparisons. I have come across it in relation to PD-studies for nasal steroids, inhaled products and biosimilar. FDA previously considered it in relation to BE for endogenous compounds. You can read briefly about the fate of ANCOVA for KCl BE here.

If you feel a sudden urge to include covariates in your models then I'd suggest you to seek sc. advice before spending too much money on it.

Would be funny and challenging, by the way, to simulate 2-stage approaches with covariates