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Comparison of 500 spontaneous and 500 published reports of adverse drug reactions
F Haramburu1, B Bégaud, J C Péré
1Centre de Pharmacovigilance, Hôpital Pellegrin, Bordeaux, France.
European Journal of Clinical Pharmacology
|January 1, 1990
Abstract:
The information and case quality of 500 spontaneous and 500 published adverse drug reaction (ADR) reports were compared, including a study of the most common criteria used in different causality assessment methods. The criteria were more often of positive value in the published reports. Nevertheless, spontaneous reports play an important role in the detection of new ADRs.