Bioequivalence and Bioavailability Forum

Dear VM,

CoA of what:
- of the investigational medicinal product administered to the subjects ? I would say yes. You want to be sure of what you give the subject. Not as important as in a BE (where you want to know the difference between T and R), but there is still an ethical concern.
- of the reference material you use in the lab to spike the standards and QCs ? This can be discussed more. On the one hand this is just a development study, so not regulated by guidelines. On the other hand you need some guarantee on whatever material you are going to use (You don't really care whether it is 99.9 or 99.8 % pure, but if it is just 80 %...). The answer depends on the source of the product and on the final goal of the study (what information do you want to get when giving only the reference product ?).

Regards
Ohlbe