アブストラクト | The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a database for postmarketing drug safety monitoring and influences changes in FDA safety guidance documents such as drug labels. The number of cases in the FAERS has rapidly increased with the improvement of submission methods and data standards and thus has become an important resource for regulatory science. Although the FAERS has been predominantly used for safety signal detection, this study explored its utility for disease characteristics. |
ジャーナル名 | Clinical pharmacology and therapeutics |
Pubmed追加日 | 2014/1/23 |
投稿者 | Fang, H; Su, Z; Wang, Y; Miller, A; Liu, Z; Howard, P C; Tong, W; Lin, S M |
組織名 | Office of Scientific Coordination, National Center for Toxicological Research, US;Food and Drug Administration, Jefferson, Arkansas, USA.;Division of Bioinformatics and Biostatistics, National Center for Toxicological;Research, US Food and Drug Administration, Jefferson, Arkansas, USA.;Biomedical Informatics Research Center, Marshfield Clinic Research Foundation,;Marshfield, Wisconsin, USA. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24448476/ |