Exploring the FDA Adverse Event Reporting System to Generate Hypotheses for Monitoring of Disease Characteristics

被引：54

作者：

Fang, H. ^{[1
]}

Su, Z. ^{[2
]}

Wang, Y. ^{[2
]}

Miller, A. ^{[3
]}

Liu, Z. ^{[2
]}

Howard, P. C. ^{[1
]}

Tong, W. ^{[2
]}

Lin, S. M. ^{[3
]}

机构：

[1] US FDA, Off Sci Coordinat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA

[2] US FDA, Div Bioinformat & Biostat, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA

[3] Marshfield Clin Res Fdn, Biomed Informat Res Ctr, Marshfield, WI USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2014年 / 95卷 / 05期

基金：

美国国家卫生研究院;

关键词：

RISK;

D O I：

10.1038/clpt.2014.17

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：496 / 498

页数：3

共 5 条

[1] The Unified Medical Language System (UMLS): integrating biomedical terminology [J].

Bodenreider, O .

NUCLEIC ACIDS RESEARCH, 2004, 32 :D267-D270

[2] Risk Factors Associated with Ischemic Optic Neuropathy after Spinal Fusion Surgery [J].

Lee, Lorri A. ;

Roth, Steven ;

Todd, Michael M. ;

Posner, Karen L. ;

Polissar, Nayak L. ;

Neradilek, Moni B. ;

Torner, James ;

Newman, Nancy J. ;

Domino, Karen B. ;

Lauer, Kathryn K. ;

Buddithi, Rachel ;

Gollapudy, Suneeta ;

Pajewski, Thomas N. ;

Scalzo, David C. ;

Avitsian, Rafi ;

Brown, Michael J. ;

Buenvenida, Shonie ;

Mashour, George A. ;

Moore, Laurel E. ;

Samra, Satwant K. ;

Lieberman, Jeremy ;

Lane, Rondall K. ;

Ramani, Ramachandran ;

Wagner, Jessica ;

Tempelhoff, Rene ;

Monsey, Cynthia M. ;

Robicsek, Steven A. ;

Vu, Melissa M. ;

Weeks, Julie ;

Manninen, Pirjo H. ;

Fu, Eugene S. ;

Sanchez-Yanes, Greys C. ;

Peterfreund, Robert A. ;

Albrecht, Meredith A. ;

Sapire, Kenneth J. ;

Baughman, Verna L. ;

Caplan, Robert A. ;

Cheney, Frederick W. ;

Metzner, Julia .

ANESTHESIOLOGY, 2012, 116 (01) :15-24

[3] More eyeballs on AERS [J].

Pratt, Leslie A. ;

Danese, Paul N. .

NATURE BIOTECHNOLOGY, 2009, 27 (07) :601-602

[4] Epidemiology of acne in the general population:: the risk of smoking [J].

Schäfer, T ;

Nienhaus, A ;

Vieluf, D ;

Berger, J ;

Ring, J .

BRITISH JOURNAL OF DERMATOLOGY, 2001, 145 (01) :100-104

[5] Sex differences in autoimmune disease [J].

Whitacre, CC .

NATURE IMMUNOLOGY, 2001, 2 (09) :777-780

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