Literature DB >> 9915089

Limitations and strengths of spontaneous reports data.

S A Goldman1.   

Abstract

US Food and Drug Administration (FDA) monitoring of the continued safety of marketed medical products depends greatly on spontaneous reporting of serious adverse events by health professionals. Despite its inherent limitations, the national postmarketing surveillance system provides vital information of clinical importance.

Mesh：

Year:  1998        PMID： 9915089     DOI： 10.1016/s0149-2918(98)80007-6

Source DB:  PubMed          Journal:  Clin Ther        ISSN： 0149-2918            Impact factor:   3.393


  57 in total

Review 1.  Anti-tumour necrosis factor alpha therapy in rheumatoid arthritis: an update on safety.

Authors:  K L Hyrich; A J Silman; K D Watson; D P M Symmons
Journal:  Ann Rheum Dis       Date:  2004-07-08       Impact factor: 19.103

2.  A signal detection method to detect adverse drug reactions using a parametric time-to-event model in simulated cohort data.

Authors:  Victoria R Cornelius; Odile Sauzet; Stephen J W Evans
Journal:  Drug Saf       Date:  2012-07-01       Impact factor: 5.606

3.  Texas pharmacists' opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study.

Authors:  Paul Gavaza; Carolyn M Brown; Star Khoza
Journal:  Pharm World Sci       Date:  2010-07-23

Review 4.  The art and science of risk management: a US research-based industry perspective.

Authors:  Janice K Bush; Wanju S Dai; Gretchen S Dieck; Linda S Hostelley; Thomas Hassall
Journal:  Drug Saf       Date:  2005       Impact factor: 5.606

5.  A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program.

Authors:  Kenneth Tong; Jean Paul Nicandro; Reshma Shringarpure; Emil Chuang; Lin Chang
Journal:  Therap Adv Gastroenterol       Date:  2013-09       Impact factor: 4.409

6.  Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry.

Authors:  F Tubach; D Salmon; P Ravaud; Y Allanore; P Goupille; M Bréban; B Pallot-Prades; S Pouplin; A Sacchi; R M Chichemanian; S Bretagne; D Emilie; M Lemann; O Lortholary; O Lorthololary; X Mariette
Journal:  Arthritis Rheum       Date:  2009-07

7.  Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database.

Authors:  Allen D Brinker; Jenna Lyndly; Joseph Tonning; David Moeny; Jonathan G Levine; Mark I Avigan
Journal:  Drug Saf       Date:  2013-12       Impact factor: 5.606

Review 8.  Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit.

Authors:  Rashmi R Shah; Joel Morganroth
Journal:  Drug Saf       Date:  2015-08       Impact factor: 5.606

9.  A distributed, collaborative intelligent agent system approach for proactive postmarketing drug safety surveillance.

Authors:  Yanqing Ji; Hao Ying; Margo S Farber; John Yen; Peter Dews; Richard E Miller; R Michael Massanari
Journal:  IEEE Trans Inf Technol Biomed       Date:  2009-12-11

10.  Handling Temporality of Clinical Events for Drug Safety Surveillance.

Authors:  Jing Zhao; Aron Henriksson; Maria Kvist; Lars Asker; Henrik Boström
Journal:  AMIA Annu Symp Proc       Date:  2015-11-05
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