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[Pharmacological vigilance and pharmacological epidemiology: principles, definition, methods and current trends in
J L Montastruc1, H Bagheri, M Lapeyre-Mestre
1Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Faculté de Médecine, Hôpitaux de Toulouse.
Abstract:
It is now well established that only clinical trials performed before drug approval are not sufficient for a full modern pharmacological evaluation of drugs and treatments. The need of both pharmacovigilance and pharmacoepidemiology is underlined in order to evaluate drugs under real conditions. After a summary of methods used in pharmacoepidemiological trials (spontaneous reports, imputability assessment, cohorts, case control studies etc.), recent pharmacoepidemiological data useful for the neurologist are summarized: side effects of tacrine and vaccines, serotoninergic syndrome and side effects of new antiepileptic drugs.