Showing 41 - 60 results of 2,792 for search '"drug safety"', query time: 0.77s Refine Results
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    Monitoring post-approval drug safety in pregnancy: pharmacogenetic aspects

    Published 2018-02-01
    “…The purpose of this article is to describe and to examine the utility of new pharmacogenetic approaches in monitoring post-approval drug safety in pregnancy. Data on gene expression in pregnancy and metabolic variation may, in specific instances, help to predict adverse drug reactions in the mother-placenta-fetus complex and to identify individuals at a higher risk.…”
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    Pharmacovigilance and assessment of drug safety reports during COVID 19 by Mira K Desai

    Published 2020-01-01
    “…To address the unmet medical need, the regulations are made flexible and convenient without any relaxation in drug safety reporting. The pharmacovigilance activities, especially adverse event reporting regardless of clinical trials or clinical practice should continue as usual because patient safety is the priority. …”
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    Postmarketing Surveillance: Review of Open Sources of Drug Safety Data by E. V. Shubnikova

    Published 2024-10-01
    Subjects: “…adverse drug reaction, drug safety, regulatory authorities, postmarketing surveillance, postmarketing safety drug monitoring, benefit-risk assessment, postmarketing data sources, spontaneous reporting system, signal management, pharmacovigilance database, communications in pharmacovigilance…”
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    Characteristics of drug safety alerts issued by the Spanish Medicines Agency by Eva Montané, Eva Montané, Javier Santesmases, Javier Santesmases

    Published 2023-01-01
    “…Objectives: To describe the characteristics of safety alerts issued by the Spanish Medicines Agency (AEMPS) and the Spanish Pharmacovigilance System over a 7-year period and the regulatory actions they generated.Methods: A retrospective analysis was carried out of drug safety alerts published on the AEMPS website from 1 January 2013 to 31 December 2019. …”
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    Contribution of the Regional Drug Information Center Towards Drug Safety by Subish Palaian, P Mishra, PR Shankar, D Bista, B Pawar

    Published 2006-01-01
    “…Key Words: Drug information center, Drug information services, Drug related complications, Drug safety.…”
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    Drug safety assessment in clinical trials: methodological challenges and opportunities by Singh Sonal, Loke Yoon K

    Published 2012-08-01
    “…Regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety.</p>…”
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    Uncertainty characterisation in action potential modelling for cardiac drug safety by Johnstone, R

    Published 2018
    “…Following a workshop in July, 2013 at the US Food and Drug Administration (FDA), the <em>Comprehensive in-vitro Proarrhythmia Assay</em> (CiPA) initiative was proposed to improve safety testing, led by a number of drug safety and regulatory bodies around the world. …”
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