Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety (Record no. 38365)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02494naaaa2200337uu 4500 |
| 001 - CONTROL NUMBER | |
| control field | https://directory.doabooks.org/handle/20.500.12854/70277 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | intechopen.79986 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.5772/intechopen.79986 |
| Terms of availability | doi |
| 041 0# - LANGUAGE CODE | |
| Language code of text/sound track or separate title | English |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MBN |
| Source | bicssc |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Cosimo Antonazzo, Ippazio |
| Relationship | auth |
| 245 10 - TITLE STATEMENT | |
| Title | Chapter Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Name of publisher, distributor, etc. | InTechOpen |
| Date of publication, distribution, etc. | 2019 |
| 506 0# - RESTRICTIONS ON ACCESS NOTE | |
| Terms governing access | Open Access |
| Source of term | star |
| Standardized terminology for access restriction | Unrestricted online access |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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. |
| 540 ## - TERMS GOVERNING USE AND REPRODUCTION NOTE | |
| Terms governing use and reproduction | Creative Commons |
| Use and reproduction rights | https://creativecommons.org/licenses/by/3.0/ |
| Source of term | cc |
| -- | https://creativecommons.org/licenses/by/3.0/ |
| 546 ## - LANGUAGE NOTE | |
| Language note | English |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Public health & preventive medicine |
| Source of heading or term | bicssc |
| 653 ## - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | pharmacovigilance, signal, spontaneous reporting system, disproportionality analysis |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Salvo, Francesco |
| Relationship | auth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Raschi, Emanuel |
| Relationship | auth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pariente, Antoine |
| Relationship | auth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Moretti, Ugo |
| Relationship | auth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Poluzzi, Elisabetta |
| Relationship | auth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | De Ponti, Fabrizio |
| Relationship | auth |
| 773 10 - HOST ITEM ENTRY | |
| Host Biblionumber | OAPEN Library ID: ONIX_20210602_10.5772/intechopen.79986_434 |
| Control subfield | nnaa |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Host name | www.oapen.org |
| Uniform Resource Identifier | <a href="https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf">https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf</a> |
| Access status | 0 |
| Public note | DOAB: download the publication |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Host name | www.oapen.org |
| Uniform Resource Identifier | <a href="https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf">https://library.oapen.org/bitstream/20.500.12657/49320/1/63595.pdf</a> |
| Access status | 0 |
| Public note | DOAB: download the publication |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Host name | www.oapen.org |
| Uniform Resource Identifier | <a href="https://directory.doabooks.org/handle/20.500.12854/70277">https://directory.doabooks.org/handle/20.500.12854/70277</a> |
| Access status | 0 |
| Public note | DOAB: description of the publication |
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