Bioequivalence studies worldwide are highly regulated and a series of guideline defines in detail how such studies are to be performed. But in a lot of cases the questions to be answered by BE trials require approaches different from the “normal case”. Drug products for which systemic availability is not linked with efficacy and safety, devices and drug products with non-oral administration and bioequivalence studies with patient population require tailor-made solutions.
This workshop provides insight into solution finding based on examples presented by experts.
