[Regulatory status of safety pharmacology. Implications].
Safety Pharmacology is now specified by various European and international guidelines. The ICHS7A text, which has now been implemented, requires all new compounds to be tested before any administration in humans. The compound should be evaluated under GLPs for its potential effects on so-called vital functions (cardio-vascular, respiratory and central nervous system). Also, the potential risk for QT prolongation and Torsades de Pointes should be appropriately assessed using in vitro and in vivo models (CPMP/986/96 and draft ICHS7B) before the initiation of Phase I. Various other European or international guidelines relate to more specific evaluations: abuse liability, anti-osteoporotic compounds, etc. Safety Pharmacology should also, as other studies required for regulatory submission, be conform to the electronic records and signature constraints (CFR23 part 11 for the USA) and to the format of the Common Technical Document (ICHM4). To address all these requirements, the pharmaceutical industry should now be creating specially assigned Safety Pharmacology teams.
Département de Pharmacologie Générale, Sanofi-Synthelabo Recherche, Rue du Pr Blayac, 34184 Montpellier, France. alain.barbier@sanofi-synthelabo.com
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D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D014481:United States