| 000 | 02494naaaa2200337uu 4500 | ||
|---|---|---|---|
| 001 | https://directory.doabooks.org/handle/20.500.12854/70277 | ||
| 020 | _aintechopen.79986 | ||
| 024 | 7 |
_a10.5772/intechopen.79986 _cdoi |
|
| 041 | 0 | _aEnglish | |
| 042 | _adc | ||
| 072 | 7 |
_aMBN _2bicssc |
|
| 100 | 1 |
_aCosimo Antonazzo, Ippazio _4auth |
|
| 700 | 1 |
_aSalvo, Francesco _4auth |
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| 700 | 1 |
_aRaschi, Emanuel _4auth |
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| 700 | 1 |
_aPariente, Antoine _4auth |
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| 700 | 1 |
_aMoretti, Ugo _4auth |
|
| 700 | 1 |
_aPoluzzi, Elisabetta _4auth |
|
| 700 | 1 |
_aDe Ponti, Fabrizio _4auth |
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| 245 | 1 | 0 | _aChapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| 260 |
_bInTechOpen _c2019 |
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| 506 | 0 |
_aOpen Access _2star _fUnrestricted online access |
|
| 520 | _aThis 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. | ||
| 540 |
_aCreative Commons _fhttps://creativecommons.org/licenses/by/3.0/ _2cc _4https://creativecommons.org/licenses/by/3.0/ |
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| 546 | _aEnglish | ||
| 650 | 7 |
_aPublic health & preventive medicine _2bicssc |
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| 653 | _apharmacovigilance, signal, spontaneous reporting system, disproportionality analysis | ||
| 773 | 1 | 0 |
_0OAPEN Library ID: ONIX_20210602_10.5772/intechopen.79986_434 _7nnaa |
| 856 | 4 | 0 |
_awww.oapen.org _uhttps://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf _70 _zDOAB: download the publication |
| 856 | 4 | 0 |
_awww.oapen.org _uhttps://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf _70 _zDOAB: download the publication |
| 856 | 4 | 0 |
_awww.oapen.org _uhttps://directory.doabooks.org/handle/20.500.12854/70277 _70 _zDOAB: description of the publication |
| 999 |
_c38365 _d38365 |
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