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 a s the conditions in which these studies must he performed to ensure the saf e use of new molecules when they are administered to man. This presentation attempts to give a comparative analysis of these documents and to place th em in the context of future international harmonization.