薬物疫学と医薬品の安全性の進歩

概要

Systematic Approach to Pharmacovigilance beyond the Limits: The Southern Network on Adverse Reactions (SONAR) Projects

Kevin Lu Z, Samuel J Kessler BA, Richard Schulz, John Bian, Brian Chen JD, Jun Wu, Virginia Noxon, Gowtham A Rao, Ramie Leibnitz, John Restaino, Whitney Maxwell, LeAnn B Norris, Zaina P Qureshi, Linda Martin, Bryan L Love, Brandon Bookstaver, Scott Sutton, Raja Fayad, Sony Jacob, Peter Georgantopoulos, Oliver Sartor, Paul RYarnold, Dina

As of 2013, the Southern Network on Adverse Reactions (SONAR) team described 50 significant adverse drug reactions (sADRs) associated with FDA approved drugs. The team also investigates policy issues surrounding pharmacovigilance. Herein we describe the systematic approach to pharmacovigilance taken by the Southern Network on Adverse Reactions and discuss major findings from the group. By 2015, the team hopes to have identified 20 additional sADRs focusing on biologics, biosimilars, and biobetters. The ultimate goal of SONAR is to decrease the timescale between ADR detection and the dissemination of information regarding the sADR