Panvigilance: integrating biomarkers in clinical trials for systems pharmacovigilance

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dc.authoridSemra Şardaş / 0000-0001-5456-8636
dc.authoridAslıgül Kendirci / 0000-0003-4366-0810
dc.authorscopusidSemra Şardaş / 7003286974
dc.authorwosidSemra Şardaş / J-2175-2018
dc.authorwosidAslıgül Kendirci / M-4617-2018
dc.contributor.authorŞardaş, Semra
dc.contributor.authorKendirci, Aslıgül
dc.date.accessioned2020-08-30T20:06:57Z
dc.date.available2020-08-30T20:06:57Z
dc.date.issued2019
dc.departmentİstinye Üniversitesi, Eczacılık Fakültesi, Eczacılık Teknolojisi Bölümüen_US
dc.description.abstractDrug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such as artificial intelligence. However, we need new ideas and application contexts for integration of biomarkers and emerging technologies in modern pharmacovigilance. A new concept, panvigilance, has been recently introduced for proactive "stress testing" of new drug candidates in panels of patients or healthy volunteers identified by biomarkers, and who are situated in population edges in terms of pharmacokinetic (PK) and/or molecular target interindividual variability. Panvigilance aims to provide upper and lower bound estimates for drug performance under conditions that mimic population edges. Subsequently, it becomes easier to extrapolate pharmacovigilance signals with regard to individuals who reside in between the population edges. In this expert review, we explain that the prefix "pan," meaning everything or all, refers to the three-pronged panvigilance goals to (1) decipher the full population scale variability in medicinal product PKs and molecular target variability, (2) empower forecasting of pharmacovigilance signals within and across populations through knowledge of biomarker variations worldwide, and (3) integration of pharmacovigilance signals across government ministries, civil society organizations, and other stakeholders through, for example, institutional innovation such as centers for panvigilance. We note that panvigilance and pharmacovigilance are complementary, and underscore the added value of panvigilance for global clinical trials. Panvigilance offers a new opportunity for meaningful biomarker application in clinical trials beyond traditional contexts such as personalized medicine. In sum, panvigilance is a systems approach to pharmacovigilance and poised to innovate risk governance in medicinal product development and clinical trials.en_US
dc.identifier.citationSardas, S., & Kendirci, A. (2019). Panvigilance: Integrating Biomarkers in Clinical Trials for Systems Pharmacovigilance. OMICS-A JOURNAL OF INTEGRATIVE BIOLOGY, 23(3), 134–137. https://doi.org/10.1089/omi.2019.0020en_US
dc.identifier.doi10.1089/omi.2019.0020en_US
dc.identifier.endpage137en_US
dc.identifier.issn1536-2310en_US
dc.identifier.issn1557-8100en_US
dc.identifier.issue3en_US
dc.identifier.pmid30822263en_US
dc.identifier.scopus2-s2.0-85063130415en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpage134en_US
dc.identifier.urihttps://doi.org/10.1089/omi.2019.0020
dc.identifier.urihttps://hdl.handle.net/20.500.12713/660
dc.identifier.volume23en_US
dc.identifier.wosWOS:000461491900002en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.institutionauthorŞardaş, Semraen_US
dc.institutionauthorKendirci, Aslıgülen_US
dc.language.isoenen_US
dc.publisherMary Ann Liebert, Incen_US
dc.relation.ispartofOmics-A Journal of Integrative Biologyen_US
dc.relation.publicationcategoryDiğeren_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectPanvigilanceen_US
dc.subjectPharmacovigilanceen_US
dc.subjectClinical Trialsen_US
dc.subjectAdverse Drug Reactionsen_US
dc.subjectDrug Safetyen_US
dc.subjectCenters For Panvigilanceen_US
dc.titlePanvigilance: integrating biomarkers in clinical trials for systems pharmacovigilanceen_US
dc.typeReview Articleen_US

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