Results 111 to 120 of about 51,036 (300)

Pharmacovigilance: A Necessary Tool for Drug Safety Monitoring Globally: Pharmacovigilance

Pharmacovigilance, which is like a parasol to define the procedures for monitoring and analysing adverse drug reactions (ADRs), is a crucial part of efficient clinical practise, public health initiatives, and drug control systems.
Mansuri, Asra, Zaman, Tabrez Uz
core   +1 more source

Lithium‐related adverse drug reactions in children: A case–control study comparing lithium to second‐generation antipsychotics in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to improve the understanding of lithium's safety profile by analysing the frequency and distribution of reported adverse drug reactions (ADRs) compared to second‐generation antipsychotics (SGAs). Methods Individual case safety reports from VigiBase (1968–October 2023) involving individuals older than 2 years, with lithium or SGAs ...
Lisa T. Ringeling, Ravish N. Gangapersad, Lillian Lieuw, Patrick C. Souverein, Eibert R. Heerdink, Pilar Garcia‐Gomez, Manon H. J. Hillegers, Birgit C. P. Koch, Bram Dierckx   +8 more
wiley   +1 more source

Pharmacovigilance au quotidien [PDF]

, 2014
Objectif : La pharmacovigilance fait partie de la prévention tertiaire puisqu'elle a pour but de surveiller l'apparition de complications et de les prévenir.
Chibani, Djamila, Lescrenier, Cécile, Jamoulle, Marc, Henry, Anne Pascal   +3 more
core   +2 more sources

Pharmacovigilance update [Pharmacovigilance update]

, 2010
Main pharmacovigilance signals and alerts issued in 2009 are reviewed. Efalizumab was withdrawn from the market due to increased risks, including progressive multifocal leukoencephalopathy (PML) and questionable efficacy. New cases of PML are still being reported with rituximab and natalizumab.
Livio, F., Ivanyuk, A., Biollaz, J., Rothuizen, L., Buclin, T.   +4 more
openaire   +1 more source

Prevalence of pregnancy and birth outcomes following biologic exposure in immune‐mediated inflammatory diseases: A population‐based study

British Journal of Clinical Pharmacology, EarlyView.
Aims Almost 5% of pregnancies are affected by immune‐mediated inflammatory diseases (IMIDs). As treatments become available, understanding their use during pregnancy is important. We aimed to describe maternal, pregnancy and infant outcomes among IMID pregnancies exposed to biologic therapies. Methods Using the Merative™ MarketScan® Commercial Database,
Leah K. Flatman, Lisiane F. Leal, Gabra Nohmie, Anick Bérard   +3 more
wiley   +1 more source

Estimation of Symptomatic Respiratory Syncytial Virus Infection Incidence in Adults in Multiple Countries: A Time-Series Model-Based Analysis Protocol

Infectious Diseases and Therapy
Introduction Estimating respiratory syncytial virus (RSV) burden in adults is challenging because of non-specific symptoms, infrequent standard-of-care testing, resolution of viral shedding before seeking medical care, test positivity that varies by ...
Robin Bruyndonckx, Aleksandra Polkowska-Kramek, Caihua Liang, Charles Nuttens, Thao Mai Phuong Tran, Bradford D. Gessner, Elizabeth Begier   +6 more
doaj   +1 more source

Analysis of regulatory review models and approval timelines across selected African medicines regulatory authorities using the OpERA framework (2020–2024)

British Journal of Clinical Pharmacology, EarlyView.
Background The World Health Organization (WHO) developed the Global Benchmarking Tool (GBT) to assess national regulatory systems and support regulatory‐system strengthening across regulatory functions. Several African National Medicines Regulatory Authorities (NMRAs) have achieved Maturity Level 3 (ML3).
Constance Sakala Chisha, Stephanie Leigh, Makomani Siyanga, Grace Matimba, Richard Rukwata, Mercy Owusu‐Asante, Kwabena Frimpong‐Manso Opuni, Pratibha Sobrun, Boitumelo Semete‐Makokotlela, Adem Kermad, Stuart Walker   +10 more
wiley   +1 more source

Strengthening adverse drug reaction reporting in Nepal

Asian Journal of Medical Sciences, 2015
Pharmacovigilance in Nepal is still in infancy. Till date only healthcare professionals are involved and the problem of underreporting is seen.
Nisha Jha
doaj   +1 more source

Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting

, 2017
Muhammad Abdul Hadi,1 Chin Fen Neoh,2 Rosdi M Zin,3 Mahmoud E Elrggal,4 Ejaz Cheema4 1School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK; 2Collaborative Drug Discovery Research Group, Faculty of Pharmacy, Universiti ...
Zin RM, Neoh CF, Cheema E, Hadi MA, Elrggal ME   +4 more
core  

Unsupervised machine learning for multi‐system adverse event pattern detection in pharmacovigilance: A proof‐of‐concept analysis of fluoroquinolone reports in FAERS

British Journal of Clinical Pharmacology, EarlyView.
. Aims Traditional pharmacovigilance detects single drug–event associations but cannot readily characterize multi‐system adverse‐event patterns such as fluoroquinolone‐associated disability. We evaluated unsupervised machine learning for this purpose, using fluoroquinolones as an exemplar.
Niaz Chalabianloo, Sheikh S. Abdullah, Kamran Sedig, Flory T. Muanda   +3 more
wiley   +1 more source