Bioequivalence and Bioavailability Forum

Dear All,

In the revised USFDA draft guidance on capacitabine tablet bioequivalence study, it is suggested that – 'Since each patient in the study will be receiving different doses, dose should be included in the statistical model'. But in the crossover study even though different doses are used for each subject, any given subject receives the same dose of Test and Reference. Hence is there any need to include the term 'dose' in the statistical model? because each subject will acts as his/her own control providing a Test/Reference comparison which is independent of the dose of drug received. Kindly give your view on above requirement recommended in the guidance.

regards
Chak