Safety pharmacology: An essential interface of pharmacology and toxicology in the non-clinical assessment of new pharmaceuticals

Toxicology Letters

Volumn 151, Issue 1, 2004, Pages 25-28

  Claude, Jean Roger ^a   Claude, Nancy ^b  

^a Faculty of Pharmacy   (France)

^b IRIS Institut de Recherches Internationales Servier   (France)

Author keywords

Committee for the Proprietaries of Medicinal Products; CPMP; EMEA; EPHAR; European Medicines Evaluation Agency; European Pharmacological Society; FDA; Food and Drug Administration; GLP; good laboratory practices; ICH; International Conference on Harmonisation

Indexed keywords

ANIMAL WELFARE; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; EXPERIMENTAL ANIMAL; FUTUROLOGY; HEALTH CARE POLICY; HUMAN; MANDATORY TESTING; METHODOLOGY; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS; REVIEW; RISK ASSESSMENT;

EID: 2942511568     PISSN: 03784274     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.toxlet.2004.02.017     Document Type: Article

References (4)

1. Anon., 2000. Guideline on safety pharmacology studies for human pharmaceuticals S7A. Vth International Conference on Harmonisation.
2. Anon., in preparation. Guideline on safety pharmacology studies for assessing the potential for delayed ventricular repolarisation by human pharmaceuticals S7B. VIth International Conference on Harmonisation.
3. Claude J.R. Safety pharmacology in the non-clinical assessment of new medicinal products: definition, place, interest and difficulties. Fundam. Clin. Pharmacol. 16:2002;75-78
4. Spindler P., Seiler J.P. The quality management of pharmacology and Safety pharmacology studies. Fundam. Clin. Pharmacol. 16:2002;83-90