SIGNAL AS A TOOL OF THE PHARMACOVIGILANCE
The European Medical Agency (EMA) in 2012 formulated modern legislation defining the procedure for pharmacovigilance — the Good Pharmacovigilance Practices (GVP), which replaced the earlier provisions of the Pharmacovigilance Guidelines for Human Medicines. The signal management position is included...
Uložené v:
| Vydané v: | Bezopasnostʹ i risk farmakoterapii (Online) Ročník 6; číslo 2; s. 61 - 67 |
|---|---|
| Hlavní autori: | , , , , |
| Médium: | Journal Article |
| Jazyk: | English Russian |
| Vydavateľské údaje: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products
21.06.2018
|
| Predmet: | |
| ISSN: | 2312-7821, 2619-1164 |
| On-line prístup: | Získať plný text |
| Tagy: |
Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
|
| Abstract | The European Medical Agency (EMA) in 2012 formulated modern legislation defining the procedure for pharmacovigilance — the Good Pharmacovigilance Practices (GVP), which replaced the earlier provisions of the Pharmacovigilance Guidelines for Human Medicines. The signal management position is included in one of the GVP EMA modules and became part of the EAEC GVP Rules. EMA in 2017 published a regulatory guide for detecting a signal in spontaneous reporting databases, which became an Annex to Module IX of the GVP Rules «Signal Management». The approach proposed in the Appendix supplements the classical analysis of disproportionality with other data, based on both statistical and clinical judgments. The article deals with the problem of detecting signals about the safety of medicines. The main parameters that determine the effectiveness of methods for detecting signals on disproportionality and allowing to compare the productivity of different statistical methods with respect to each other are considered. Priority directions are considered when evaluating the signal, and key elements of a qualitative method for detecting signals are drawn up, taking into account the expert opinion. |
|---|---|
| AbstractList | The European Medical Agency (EMA) in 2012 formulated modern legislation defining the procedure for pharmacovigilance — the Good Pharmacovigilance Practices (GVP), which replaced the earlier provisions of the Pharmacovigilance Guidelines for Human Medicines. The signal management position is included in one of the GVP EMA modules and became part of the EAEC GVP Rules. EMA in 2017 published a regulatory guide for detecting a signal in spontaneous reporting databases, which became an Annex to Module IX of the GVP Rules «Signal Management». The approach proposed in the Appendix supplements the classical analysis of disproportionality with other data, based on both statistical and clinical judgments. The article deals with the problem of detecting signals about the safety of medicines. The main parameters that determine the effectiveness of methods for detecting signals on disproportionality and allowing to compare the productivity of different statistical methods with respect to each other are considered. Priority directions are considered when evaluating the signal, and key elements of a qualitative method for detecting signals are drawn up, taking into account the expert opinion. |
| Author | Zhuravleva, E. O. Darmostukova, M. A. Kutekhova, G. V. Velts, N. Yu Alyautdin, R. N. |
| Author_xml | – sequence: 1 givenname: E. O. surname: Zhuravleva fullname: Zhuravleva, E. O. – sequence: 2 givenname: N. Yu surname: Velts fullname: Velts, N. Yu – sequence: 3 givenname: G. V. surname: Kutekhova fullname: Kutekhova, G. V. – sequence: 4 givenname: M. A. surname: Darmostukova fullname: Darmostukova, M. A. – sequence: 5 givenname: R. N. surname: Alyautdin fullname: Alyautdin, R. N. |
| BookMark | eNo9kMtOwzAQRS1UJErpP4QlC4PHby-tqG0ihQbRwtayExsFlQYlbPh7-gBWczW6Olc612iy7_cRoVsg94xoIx4oA4qVpoApAY0lplgCluoCTakEgwEknxzyX-0KzcexC4QrpjhneoruNuVqbavMbjKbbeu6yuplti0W2VNhnx9tXr-Wq7Ky63xxgy6T341x_ntn6GW52OYFrupVmdsKNyCVwm3g3KfQGKFaGgURomXChCAMaJq0EoxLSTgjIrVBaa2DiF5pETxEJRJlM1SeuW3v393n0H344dv1vnOnRz-8OT98dc0uOt0eNpjSnJvEvWYmBqJAN162hjMjDyxzZjVDP45DTP88IO6k0B3duKMbd1TopKNOgpOK_QDLO19n |
| ContentType | Journal Article |
| DBID | AAYXX CITATION DOA |
| DOI | 10.30895/2312-7821-2018-6-2-61-67 |
| DatabaseName | CrossRef DOAJ Directory of Open Access Journals |
| DatabaseTitle | CrossRef |
| DatabaseTitleList | |
| Database_xml | – sequence: 1 dbid: DOA name: DOAJ Directory of Open Access Journals url: https://www.doaj.org/ sourceTypes: Open Website |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 2619-1164 |
| EndPage | 67 |
| ExternalDocumentID | oai_doaj_org_article_8d7d2378449f4a839eb0718ca6d94396 10_30895_2312_7821_2018_6_2_61_67 |
| GroupedDBID | AAFWJ AAYXX ALMA_UNASSIGNED_HOLDINGS CITATION ADBBV BCNDV GROUPED_DOAJ |
| ID | FETCH-LOGICAL-c1677-db44afbc957d2e5055d359bb59182f875346604305fdb7888b5ea785ba1e75f23 |
| IEDL.DBID | DOA |
| ISSN | 2312-7821 |
| IngestDate | Fri Oct 03 12:46:15 EDT 2025 Sat Nov 29 06:39:09 EST 2025 |
| IsDoiOpenAccess | true |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 2 |
| Language | English Russian |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c1677-db44afbc957d2e5055d359bb59182f875346604305fdb7888b5ea785ba1e75f23 |
| OpenAccessLink | https://doaj.org/article/8d7d2378449f4a839eb0718ca6d94396 |
| PageCount | 7 |
| ParticipantIDs | doaj_primary_oai_doaj_org_article_8d7d2378449f4a839eb0718ca6d94396 crossref_primary_10_30895_2312_7821_2018_6_2_61_67 |
| PublicationCentury | 2000 |
| PublicationDate | 2018-06-21 |
| PublicationDateYYYYMMDD | 2018-06-21 |
| PublicationDate_xml | – month: 06 year: 2018 text: 2018-06-21 day: 21 |
| PublicationDecade | 2010 |
| PublicationTitle | Bezopasnostʹ i risk farmakoterapii (Online) |
| PublicationYear | 2018 |
| Publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products |
| Publisher_xml | – name: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products |
| SSID | ssib047374438 ssib051327250 ssib050729409 ssj0002875994 |
| Score | 2.0306218 |
| Snippet | The European Medical Agency (EMA) in 2012 formulated modern legislation defining the procedure for pharmacovigilance — the Good Pharmacovigilance Practices... |
| SourceID | doaj crossref |
| SourceType | Open Website Index Database |
| StartPage | 61 |
| SubjectTerms | disproportionality methods drug safety efficiency of the signal detection system pharmacovigilance signal signal detection algorithm |
| Title | SIGNAL AS A TOOL OF THE PHARMACOVIGILANCE |
| URI | https://doaj.org/article/8d7d2378449f4a839eb0718ca6d94396 |
| Volume | 6 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVAON databaseName: DOAJ Directory of Open Access Journals customDbUrl: eissn: 2619-1164 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0002875994 issn: 2312-7821 databaseCode: DOA dateStart: 20150101 isFulltext: true titleUrlDefault: https://www.doaj.org/ providerName: Directory of Open Access Journals – providerCode: PRVHPJ databaseName: ROAD: Directory of Open Access Scholarly Resources customDbUrl: eissn: 2619-1164 dateEnd: 99991231 omitProxy: false ssIdentifier: ssib050729409 issn: 2312-7821 databaseCode: M~E dateStart: 20150101 isFulltext: true titleUrlDefault: https://road.issn.org providerName: ISSN International Centre |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV1JSwMxGA0iIl7EFXciiCAYnCXrcSytLdS2aBVvIclMQA8qdYFe_O1-yVSnNy9e5hCYQN734PveLO8hdEKDp413hljuLKGpcMRAVyKCOS9LyzLuY6X7YjCQDw9qNBf1Fb4Jq-2Ba-AuZCnKLBeSUuWpgXZeWeiK0hleKmim0Ww7EWpOTAGTqMgFpQ2zWPDHpo1RFQMNJn7e5z3FR0yCqZiaCPMOjJwyS5fRcZC0iVTs4ncRSJVKwkkGkovEbPqmmc15_sfm1FlDq7OpEhf1adbRwuRjA52Oalvq6TkeN39ZvZ3jUzxqDKunm-jstnc1KPq4uMUFHg-HfTzs4HG3jUfd4ua6aA3ve1e9mGKzhe467XGrS2YRCsSlXAhSWkqNt04xQLGCaYeVOVPWMgW6wgetQjmPtl--tEENW1YZIZk1aSWYz_JttPj88lztIJwYn4sqCdHpEgpRmgp2yXgO2ytneb6Lsh8s9GvtlKFBYUQAdQBQBwB1AFBznWmeai520WVA7feGYHYdF4ACekYB_RcF9v5jk320EmubQHHTA7T4PvmoDtGS-3x_fJscRXbB9fqr_Q2I5sQi |
| linkProvider | Directory of Open Access Journals |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=SIGNAL+AS+A+TOOL+OF+THE+PHARMACOVIGILANCE&rft.jtitle=Safety+and+Risk+of+Pharmacotherapy&rft.au=Zhuravleva%2C+E.+O.&rft.au=Velts%2C+N.+Yu&rft.au=Kutekhova%2C+G.+V.&rft.au=Darmostukova%2C+M.+A.&rft.date=2018-06-21&rft.issn=2312-7821&rft.volume=6&rft.issue=2&rft.spage=61&rft.epage=67&rft_id=info:doi/10.30895%2F2312-7821-2018-6-2-61-67&rft.externalDBID=n%2Fa&rft.externalDocID=10_30895_2312_7821_2018_6_2_61_67 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2312-7821&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2312-7821&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2312-7821&client=summon |