Clinical significance of bioequivalence and interchangeability

of NTR drugs - Focus on warfarin (1)

• Published literatures describing lack of efficacy or even

significant toxicity resulting from :

– administration of generic warfarin to patients previously stabilized

on Coumadin, or
– switching between generic and Coumadin.

Dr. GG. Zhanel, Health Sciences Centre, MS673 - 820 Sherbrook Street, Winnipeg, Manitoba,
R3A 1R9, Canada
Clinical significance of bioequivalence and interchangeability
of NTR drugs - Focus on warfarin (2)

• Although BA studies (in healthy volunteers) suggest that average AUC

and Tmax are not different between generic and Coumadin,
significant differences occur when individual patients are analyzed.
• Therefore, switchability between products cannot be assured.

• Limited clinical study is available describing adverse clinical

consequences of switching between brand name and generic
warfarin.
• Cases in Indonesia.