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| http://dx.doi.org/10.1002/jcsm.12083 | DOI Listing |
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Interventions to reduce non-prescription antimicrobial sales in community pharmacies.
Cochrane Database Syst Rev
January 2025
Global Health Nursing, Graduate School of Nursing Science, St. Luke's International University, Chuo-ku, Japan.
Background: Antimicrobial resistance (AMR) is a major global health concern. One of the most important causes of AMR is the excessive and inappropriate use of antimicrobial drugs in healthcare and community settings. Most countries have policies that require antimicrobial drugs to be obtained from a pharmacy by prescription.
View Article and Find Full Text PDFUnlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.
View Article and Find Full Text PDFDuration of Time Intervals for Risk Minimization Measure Effectiveness Studies.
Clin Pharmacol Ther
January 2025
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Insights into the time needed for evaluation of risk minimization measures' (RMMs) effectiveness might identify areas for improvement. We assessed the duration of time intervals between regulatory milestones for RMM effectiveness studies assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). We included completed RMM effectiveness post-authorization safety studies (PASSs) assessed by PRAC between 2016 and 2022.
View Article and Find Full Text PDFThe conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co-rapporteur Member State, France, for the pesticide active substance spinosad and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of spinosad as insecticide on bulb/dry onions, maize (fodder and grain), sweet corn, grapes (table and wine), lettuce, potato, aubergine, pepper and tomato.
View Article and Find Full Text PDFA Real-World Data Analysis of Alglucosidase Alfa in the FDA Adverse Event Reporting System (FAERS) Database.
Drugs R D
January 2025
Department of Pediatric Intensive Care Unit, Shandong, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 324 Jingwu Road, Ji'nan, Shandong, China.
Background And Objective: Alglucosidase alfa for injection is used as an enzyme replacement therapy for the treatment of Pompe disease. The safety profile of alglucosidase alfa-associated adverse events requires a comprehensive evaluation. In this study, we aimed to identify drug safety alert signals and investigate the real-world safety of alglucosidase alfa to guide clinical decision making and optimize the risk-benefit balance.
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