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Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient’s reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.

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Series Title
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Call Number
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Publisher
IntechOpen : InTechOpen.,
Collation
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Language
English
ISBN/ISSN
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Classification
NONE
Content Type
text
Media Type
computer
Carrier Type
online resource
Edition
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Subject(s)
pharmacovigilance
Specific Detail Info
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Statement of Responsibility
Other Information
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Source
https://directory.doabooks.org/handle/20.500.12854/70277
Validator
Suwardi
Digital Object Identifier (DOI)
10.5772/intechopen.79986
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