ABSTRACT
The clinical safety or tolerability risk of a drug is measured in terms of the incidence of a toxic event occurring versus the number of subjects treated (e.g., 2:600 = P0.003). While there has been much harmonization of principles within the ICH areas of the world, there are still different approaches to the implementation of clinical drug safety monitoring and pharmacovigilance. We will now examine these separately for the EU, U.S., and Japan.
