[General principles for safety evaluation of pharmaceuticals in man based on integration of data from various...

Safety evaluation of pharmaceuticals consists of two processes; firstly, to grade the adverse effects of a test material on individuals based on scientific evidence, and, secondly, to judge whether the adverse effects occurring under the dose condition of the material capable of exhibiting its efficacy in patients remains within the acceptable safe range. Accordingly, the basic criteria for safety evaluation of pharmaceuticals can be, simply, said to know how high the dose-response curve of adverse effects lies above that of efficacy. On the other hand, the judgement concerning how much difference is necessary between both dose-response curves with regard to the safety would require a careful consideration on a case by case basis taking into account various information on the risk/benefit balance of the drug such as 1) medical usefulness and social needs of the drug and 2) the presumed severity of adverse effects in man.