Results 11 to 20 of about 62,672 (281)

Pharmacovigilance of Biosimilars [PDF]

, 2013
In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1].
Chablani, Lipika
core   +2 more sources

Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]

, 2014
Peer reviewedPublisher ...
Bond, Christine M, Francis, Jill J, Haughney, John, Helms, Peter J, Hopf, Yvonne Marina   +4 more
core   +2 more sources

Current career situations of Chinese pharmacovigilance professionals working for pharmaceutical companies: an exploratory survey

BMC Health Services Research, 2023
Background Pharmacovigilance in China has experienced rapid development in the past 30 years. The implementation of Good Pharmacovigilance Practice in China since the end of 2021 heralds a new era of pharmacovigilance affairs, which puts forward higher ...
Yalan Tang, Yan Liu, Hongli Liao, Yonghua Yuan, Qihua Jiang   +4 more
doaj   +1 more source

Evaluation of Pharmacovigilance System in Iran [PDF]

International Journal of Health Policy and Management, 2022
BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems ...
Malahat Khalili, Hamid Sharifi, Bita Mesgarpour, Mehrnaz Kheirandish, Sten Olsson, Naghmeh Javidnikou, Ali Akbar Haghdoost   +6 more
doaj   +1 more source

Identification of International Society on Thrombosis and Haemostasis major and clinically relevant non-major bleed events from electronic health records: a novel algorithm to enhance data utilisation from real-world sources

International Journal of Population Data Science, 2023
Introduction In randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH).
Alexander Hartenstein, Khaled Abdelgawwad, Frank Kleinjung, Stephen Privitera, Thomas Viethen, Tatsiana Vaitsiakhovich   +5 more
doaj   +1 more source

Bayesian model selection in logistic regression for the detection of adverse drug reactions [PDF]

, 2015
Motivation: Spontaneous adverse event reports have a high potential for detecting adverse drug reactions. However, due to their dimension, exploring such databases requires statistical methods.
Marbac, Matthieu, Sedki, Mohammed, Tubert-Bitter, Pascale   +2 more
core   +3 more sources

The promotion of data sharing in pharmacoepidemiology [PDF]

, 2014
This article addresses the role of pharmacoepidemiology in patient safety and the crucial role of data sharing in ensuring that such activities occur. Against the backdrop of proposed reforms of European data protection legislation, it considers whether ...
Sethi, Nayha
core   +1 more source

Safety and Effectiveness of Molnupiravir (LAGEVRIO®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy, 2023
Introduction Molnupiravir is an oral antiviral drug that received special approval for emergency use in Japan on December 24 2021 for infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Masahiro Kimata, Asuka Watanabe, Yukiko Yanagida, Daisuke Kinoshita, Shinichiroh Maekawa   +4 more
doaj   +1 more source

Clinical characteristics and risk factors for cefaclor-induced immediate hypersensitivity: a retrospective observation at two university hospitals in Korea

Allergy, Asthma & Clinical Immunology, 2021
Background Cefaclor, a second-generation oral cephalosporin, is widely prescribed to treat infectious diseases. Immediate hypersensitivity (HS) reactions to cefaclor have continuously been reported and are expected to increase with its greater use.
Hyo-In Rhyou, Go-Eun Doo, Jiwon Yoon, Chae-Yeon Ha, Hee-Joo Nam, Sung-Dae Woo, Youngsoo Lee, Young-Hee Nam, Young-Min Ye   +8 more
doaj   +1 more source

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
core   +4 more sources