Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

Author:

Raschi Emanuel,Moretti Ugo,Salvo Francesco,Pariente Antoine,Cosimo Antonazzo Ippazio,De Ponti Fabrizio,Poluzzi Elisabetta

Publisher

IntechOpen

Reference121 articles.

1. Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet. 2000;356:1255-1259

2. European Parliament. Regulation (EU) 1235/2010—2010 pharmacovigilance legislation. 2010. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF

3. European Council (2010) Directive 2010/84/EU—2010 pharmacovigilance legislation. Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF

4. Laporte JR. Fifty years of pharmacovigilance—Medicines safety and public health. Pharmacoepidemiology and Drug Safety. 2016;25:725-732

5. Poluzzi E, Raschi E, Moretti U, De Ponti F. Drug-induced torsades de pointes: Data mining of the public version of the FDA adverse event reporting system (AERS). Pharmacoepidemiology and Drug Safety. 2009;18:512-518

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