From Monitoring Drug Safety to Monitoring Patient Safety: A Strategic Focus for the Activity of Pharmacists by Francisco Batel Marques

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Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports by Theodoros G. Soldatos, Sarah Kim, Stephan Schmidt, Lawrence J. Lesko, David B. Jackson

“…Several methods have been developed to analyze such data, aiming to improve pharmacovigilance and drug safety. In this work, we provide a brief review of key directions to quantitatively analyzing adverse events and explore the potential of augmenting these methods using additional molecular data descriptors. …”
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Are drug safety measures harmonized? A real-world evidence from three regulatory authorities by Sadeem Alelayan, Leena Al-Sheikh, Rana Almotawa, Hadeel Alkofide, Thamir Alshammari

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“Blind men and an elephant”: The need for animals in research, drug safety studies, and understanding civilizational diseases by Savani Anbalagan

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Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring by E. A. Sokova, V. V. Arkhipov, A. S. Kazakov, B. K. Romanov, R. N. Alyautdin, M. V. Zhuravleva

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Desloratadine and depression, a drug safety signal based on worldwide spontaneous reporting of side effects by Jeltje Boer, Ellen Ederveen, Birgitta Grundmark

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From Monitoring Drug Safety to Monitoring Patient Safety: A Strategic Focus for the Activity of Pharmacists by Francisco Batel Marques

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APPLICATION OF DRUG-RELATED PROBLEMS APPROACH TO ANALYSIS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS’ SAFETY by A. V. Matveev, A. E. Krasheninnikov, E. A. Egorova, E. I. Konyaeva

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Using Twitter Data for Cohort Studies of Drug Safety in Pregnancy: Proof-of-concept With β-Blockers by Ari Z Klein, Karen O'Connor, Lisa D Levine, Graciela Gonzalez-Hernandez

“…ConclusionsOur ability to detect pregnancy outcomes for Twitter users who posted tweets reporting that they took or may have taken a β-blocker during pregnancy suggests that Twitter can be a complementary resource for cohort studies of drug safety in pregnancy.…”
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An EGFP Knock-in Zebrafish Experimental Model Used in Evaluation of the Amantadine Drug Safety During Early Cardiogenesis by Shi Ouyang, Shi Ouyang, Wu-Ming Qin, Wu-Ming Qin, Yu-Juan Niu, Yu-Juan Niu, Yong-He Ding, Yong-He Ding, Yun Deng, Yun Deng

“…Amantadine drug treatment-induced ectopic expression of vmhc gene in the atrium and caused cardiac-looping or LR asymmetry defects to dose-dependently during early cardiogenesis, concomitant with dramatically reduced expression levels of key genes required for myocardium differentiation and LR asymmetry.ConclusionWe generated a novel zebrafish KI animal model in which EGFP reports the ventricle chamber-specific expression of vmhc gene dynamics that is useful to effectively assess drug safety on the cardiac morphology in vivo. Specifically, this study identified teratogenic effects of amantadine drug during early cardiogenesis dose dependent, which could be likely conveyed by inhibiting expression of key genes required for cardiac myocardium differentiation and LR asymmetry.…”
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A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS) by Jacqueline M. Cohen, Carolyn E. Cesta, Lars Kjerpeseth, Maarit K. Leinonen, Óskar Hálfdánarson, Øystein Karlstad, Pär Karlsson, Morten Andersen, Kari Furu, Vidar Hjellvik

“…We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. …”
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Abbreviated Profile of Drugs (APOD): modeling drug safety profiles to prioritize investigational COVID-19 treatments by Chaitanya N. Hiremath

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Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems by Schjøtt J, Bergman J

“…Keywords: pharmacovigilance, drug safety, database, pregabalin…”
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Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database by Isaac V. Cohen, Tigran Makunts, Ruben Abagyan, Kelan Thomas

“…The goal of this study was to evaluate the risks due to MDMA ingestion alone or in combination with other common medications and drugs of abuse using the FDA drug safety surveillance data. To date, nearly one thousand reports of MDMA use have been reported to the FDA. …”
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A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population by Homero Contreras-Salinas, Leopoldo Martín Baiza-Durán, Mariana Barajas-Hernández, Alan Omar Vázquez-Álvarez, Lourdes Yolotzin Rodríguez-Herrera

Subjects: “…drug safety surveillance…”
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Use of Medicines in Children: Pharmacological and Practical Issues by Shashikant Bhargava, Prashant Mishra, Shiwangi Rana

Subjects: “…Pediatric; Pharmacokinetics; Drug Safety…”
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Pharmacological therapy of osteoporosis with bisphosphonates – for whom, what kind, and for how long? by Ewa Marcinowska-Suchowierska, Magdalena Walicka

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Drug safety surveillance /Adverse drug reaction monitoring and establishing Pharmacovigilance Centres in teaching hospitals – A perspective by Shobha V. Huilgol

Subjects: “…Drug safety surveillance…”
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A tree-based scan statistic for zero-inflated count data in post-market drug safety surveillance by Goeun Park, Inkyung Jung

“…The two methods were illustrated using Korea Adverse Event Reporting System data from the Korea Institute of Drug Safety and Risk Management.…”
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Clinical relevance of alerts from a decision support system, PHARAO, for drug safety assessment in the older adults by Khedidja Hedna, Marine L. Andersson, Hanna Gyllensten, Staffan Hägg, Ylva Böttiger

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