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Pharmacovigilance and assessment of drug safety reports during COVID 19
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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Characteristics of drug safety alerts issued by the Spanish Medicines Agency
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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What is the role of antineoplastic drug safety in reimbursement decision making?
Published 2018-11-01Subjects: “…drug safety…”
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Systematic review of antiepileptic drugs’ safety and effectiveness in feline epilepsy
Published 2018-03-01Get full text
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Real-world evidence in antiretroviral therapy: drug safety data
Published 2020-05-01Get full text
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Therapeutical Management and Drug Safety in Mitochondrial Diseases—Update 2020
Published 2020-12-01Get full text
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Drug safety assessment in clinical trials: methodological challenges and opportunities
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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Quantitative approaches to drug safety: The 2022 PSP special issue
Published 2022-05-01Get full text
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Uncertainty characterisation in action potential modelling for cardiac drug safety
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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Improved drug safety through intensive pharmacovigilance in hospitalized pediatric patients
Published 2017-12-01Subjects: Get full text
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Drug-safety reporting in Polish nursing practice-Cross sectional surveys.
Published 2020-01-01“…<h4>Conclusions</h4>Nurses in Poland are insufficiently prepared to ensure drug safety conscientiously and responsibly. Training is required for Polish nurses. …”
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Social media as a source of information on drug safety and how to extract it
Published 2018-02-01Subjects: Get full text
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POST-MARKETING DRUG SAFETY RESEARCH: ANALYSIS OF RECOMMENDATIONS OF FOREIGN REGULATORS
Published 2018-09-01Get full text
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DRUG SAFETY ASSESSMENT FOR CENOBAMATE A RECENTLY FDA-APPROVED ANTIEPILEPTIC
Published 2023-10-01Get full text
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Cardiovascular implications of the COVID-19: Management of complications and drug safety concerns
Published 2022-01-01Get full text
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