Safety Sturm und Drang
Adverse drug reactions (ADRs) are common to every drug on the market, as humans differ in how they metabolize a drug and how their bodies react to intermediates and metabolites. The challenge is how to find the adverse effects in rare phenotypes. They will not be found in the normal course of events in premarketing clinical trials, as these trials are run in a limited number of patients for a limited period of time.
Indeed, under International Conference on Harmonisation (ICH) guidelines,