Detection of drug safety signals from clinical trials data: Role of SUSARs

Author:

Perez Christelle,Olivier Pascale,Lortal Barbara,Duranton Sophie,Montastruc Jean-Louis,Colin Anne-Laurène,Toulza Emilie,Becker Madlyne,Hamy Laura,Crepin Sabrina,Roussillon Caroline,Gimbert Anne,Petitpain Nadine,Salvo Francesco

Publisher

Elsevier BV

Subject

Pharmacology

Reference24 articles.

1. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview;Petrini;Ann. Ist. Super. Sanita,2014

2. Defining ‘signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions;Hauben;Drug Saf.,2009

3. The medical dictionary for regulatory activities (MedDRA);Brown;Drug Saf.,1999

4. Food, H.H.S. Drug Administration, International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability, Fed Regist 81(121) (2016) 40890-1.

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