Bioequivalence and Bioavailability Forum

Dear IMRAN,

❝ In Bioequivalence study, if formulation (Treatment) effect is significant (since ANOVA p-value is less than 0.05) for both Cmax and AUC and individually for Cmax or AUC, what we can conclude from this significant formulation effect.

Assuming that the bioequivalence is observed, inspite of significant difference in treatment effect for ANOVA, it can be inferred that the formulations are different but bioequivalent.

❝ Similarly, what we can conclude from period and sequence significant effect.

A significant period effect could reflect on following causes:

• positioning,
  
• timing,
  
• degree of physical activity,
  
• composition of food, beverages,
  
• temperature of water administered during dosing,
  
• psychological status of subjects during two periodin turn effecting the bowel transit and drug absorption.

Opinions only, with no binding.
USFDA_EMEA.