Regulatory aspects of safety pharmacology: past, present and future

Safety pharmacology, a discipline unrecognized until the last few years, is now the subject of Japanese, American, European and ICH draft guidelines. The aim of these guidelines, either of a general nature or targeted at one particular organ, is to define the necessary pharmacology studies as well as the conditions in which these studies must he performed to ensure the safe use of new molecules when they are administered to man. This presentation attempts to give a comparative analysis of these documents and to place them in the context of future international harmonization.