Results 21 to 30 of about 10,049 (144)

Real-World Use of Generic Meropenem: Results of an Observational Study

Antibiotics, 2021
Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia, Luz Adriana Aristizábal-Ruiz, Carlos Arturo Alvarez-Moreno   +2 more
doaj   +1 more source

Drug Safety Monitoring—International Information

Безопасность и риск фармакотерапии, 2020
Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on limiting the use of some medicinal products
E. V. Shubnikova, T. M. Bukatina, G. V. Kutekhova   +2 more
doaj   +1 more source

Monitoring of Foreign Drug Safety Information

Безопасность и риск фармакотерапии, 2019
Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre ...
Editorial article
doaj   +1 more source

Analysis of the decisions of foreign regulatory authorities

Безопасность и риск фармакотерапии, 2019
Analysis of  recommendations of  foreign regulatory authorities on  the  restriction of  circulation of medicines and/or the  need  for  changes in the  instructions for  their medical use  due  to changes in the safety profile, conducted by experts of ...
Relevant information
doaj   +1 more source

Analysis of Administrative Decisions of Foreign Regulatory Authorities

Безопасность и риск фармакотерапии, 2019
Analysis of administrative decisions of foreign regulatory authorities on the limitation of circulation of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the ...
Information relevant
doaj   +1 more source

Evidence-based approaches to comparing the effectiveness of modern cardiology interventions: trends, bias and prospects

Российский кардиологический журнал, 2020
The article discusses the limitations of the evidence from observational studies. Modern approaches to reducing bias in observational studies are discussed in detail, in particular, propensity score matching, which has become popular in recent years. The
S. R. Gilyarevsky, Yu. N. Belenkov
doaj   +1 more source

Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Clinical and Translational Science, 2019
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies ...
Tomoko Kawamura Okubo, Shunsuke Ono
doaj   +1 more source

Immune Checkpoint Inhibitor-Induced Pneumonitis in Non-Small Cell Lung Cancer: A Narrative Review of Incidence and Clinical Risk Factors

Current Oncology
It is well-known that immune checkpoint inhibitors (ICIs) can lead to uncommon but potentially life-threatening immune-related adverse events (irAEs) such as checkpoint-inhibitor pneumonitis (CIP).
Olexiy Aseyev, Liliia Zrielykh, Minghan Shi, Katherine Filipovic, Claire Seymour, Rabail Siddiqui, Birubi Biman   +6 more
doaj   +1 more source

Incidence, Risk Factors and Management of Adverse Events in Contemporary Real‐World Care of Children with Juvenile Idiopathic Arthritis

Arthritis Care &Research, Accepted Article.
Objective We describe the frequency, risk factors, severity, and management of actionable and serious adverse events (AAE and SAE) in children with newly diagnosed Juvenile Idiopathic Arthritis (JIA) in Canada. Methods We enrolled patients within 3 months of JIA diagnosis in the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry,
Bashayer Alnuaimi, Roberta A. Berard, Jean‐Philippe Proulx‐Gauthier, Heinrike Schmeling, Michelle Batthish, Gilles Boire, Adam M. Huber, Dax G. Rumsey, Jaime Guzman, Gaëlle Chédeville, The CAPRI registry Investigators   +10 more
wiley   +1 more source

Current Standards of Monitoring Models in Healthcare Settings

Advanced Intelligent Discovery, EarlyView.
AI/ML‐enabled medical devices are entering clinical practice faster than monitoring standards mature. This review highlights gaps in postmarket surveillance, limited use of predetermined change‐control plans, and the need for ongoing performance tracking, drift detection, explainability, and workflow‐aware governance to support safer, more reliable ...
Alan Kay, Daljit Takher, Wenting Liu, Emily Wittrup, Gilbert S. Omenn, Kayvan Najarian   +5 more
wiley   +1 more source