Literature DB >> 15073907

Epidemiologists and adverse event data--a challenge to the field.

E A Bortnichak1, W S Dai.   

Abstract

Spontaneous adverse event reports, albeit biased and incomplete data, remain very important and, frequently, are the sole data source to rely on during the postmarketing phase for regulatory decision making. However, little progress has been made in the past decade to improve the utility of these essential data. Further research that helps to improve our understanding of the extent and characteristics of adverse event reporting should be done to ensure the maximum, appropriate utilization of this highly cost-efficient data source. In addition, the authors challenge that research can and should be done to advance our understanding of the behaviour and motivations of those who report adverse events so as to improve the quality and the quantity of meaningful spontaneous adverse event reports. Copyright 1999 John Wiley & Sons, Ltd.

Year:  1999        PMID: 15073907     DOI: 10.1002/(SICI)1099-1557(199910/11)8:6<457::AID-PDS452>3.0.CO;2-S

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.890


  2 in total

1.  Life-threatening adverse drug reaction to paclitaxel. Postmarketing surveillance.

Authors:  A Ruiz-Casado; J Calzas; J García; A Soria; J Guerra
Journal:  Clin Transl Oncol       Date:  2006-01       Impact factor: 3.405

Review 2.  Active pharmacovigilance in China: recent development and future perspectives.

Authors:  Xinling Li; Haona Li; Jianxiong Deng; Feng Zhu; Ying Liu; Wenge Chen; Zhihua Yue; Xuequn Ren; Jielai Xia
Journal:  Eur J Clin Pharmacol       Date:  2018-04-10       Impact factor: 2.953

  2 in total

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