Results 71 to 80 of about 48,983 (212)

ADRIC: Adverse Drug Reactions In Children - a programme of research using mixed methods [PDF]

, 2014
Aims To comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent ...
Arnott, Janine, Belllis, J, Bird, K, Bracken, L, Conroy, E, Creswell, L, Duncan, J, Gallagher, R, Gargon, E, Nunn, T, Peak, M, Smyth, R, Turner, M, Williamson, P, Young, B   +14 more
core  

Pharmacovigilance in clinical trials

Vojnosanitetski pregled, 2007
<zakljucak> Spontano saopstavanje o nezeljenim efektima lekova u postregistracionoj fazi je od znacaja za registrovanje retkih nezeljenih efekata. Medjutim, klinicke studije omogucavaju da se pouzdano utvrdi ucestalost nezeljenih efekata, kao i da se proceni da li je toksicni potencijal leka takav da moze omoguciti njegovu bezbednu primenu ...
Nenad D. Ugrešić, Katarina Ilic
openaire   +4 more sources

Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system

Andrology, EarlyView.
Abstract Background Growing evidence indicates that paternal condition significantly influences pregnancy outcomes and offspring health. However, assessing the safety of paternal drug exposure via randomized controlled trials poses ethical challenges, and relevant clinical studies consume a lot of resources to evaluate only a few drugs.
Yanbin Zeng, Wanlong Lin, Wei Zhuang
wiley   +1 more source

Cardiovascular safety of testosterone therapy—Insights from the TRAVERSE trial and beyond: A position statement of the European Expert Panel for Testosterone Research

Andrology, EarlyView.
Abstract Introduction Testosterone therapy has become a cornerstone treatment for men with hypogonadism, offering significant benefits such as improved sexual function, mood, muscle mass, and bone density. However, concerns about its cardiovascular safety have historically tempered its use.
Michael Zitzmann, Giulia Rastrelli, Robert D Murray, David Edwards, Yacov Reisman, Preethi Mohan Rao, Alexander Sahi, Thomas Hugh Jones, Alberto Ferlin, Eleni Armeni, Emiliano Corpas, Jann‐Frederik Cremers, Janine David, Stefan Arver, Leen Antonio, Giovanni Corona   +15 more
wiley   +1 more source

Perampanel monotherapy in pediatric epilepsy: Emphasizing the need for comprehensive safety evaluation

Epilepsia Open, EarlyView.
Gabriel Christian de Farias Morais, Guilherme Bastos Alves, Shahina Akter, Shopnil Akash, Md. Aktaruzzaman, Md. Sakib Al Hasan, Umberto Laino Fulco, Edilson Dantas da Silva Junior, Jonas Ivan Nobre Oliveira   +8 more
wiley   +1 more source

Semaglutide and non‐arteritic anterior ischaemic optic neuropathy: Review and interpretation of reported association

Acta Ophthalmologica, EarlyView.
Abstract This review covers a seminal study of the relation between exposure to the glucagon‐like peptide 1 (GLP‐1) agonist semaglutide and incident non‐arteritic anterior ischaemic optic neuropathy (NAION) in a neuro‐ophthalmology clinic setting, subsequent studies in unselected populations, a meta‐analysis of clinical trials and pathophysiology ...
Abdullah Amini, Steffen Hamann, Michael Larsen   +2 more
wiley   +1 more source

Pharmacovigilance in Italy: An overview

Journal of Pharmacology and Pharmacotherapeutics, 2013
Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance. In fact, ADRs are associated with a high degree of morbidity and mortality. However, underreporting by all healthcare professionals remains the major problem in Italy and in the rest of the world.
Mazzitello, Carmela, Esposito, Stefania, De Francesco, Adele, CAPUANO, Annalisa, Russo, Emilio, De Sarro, Giovambattista   +5 more
openaire   +4 more sources

Cannabinoids for Medical Purposes in Children: A Living Systematic Review

Acta Paediatrica, EarlyView.
ABSTRACT Aim We developed a living systematic review (LSR) that will continuously map the safety and reported benefit data related to cannabinoid use for medical purposes in children. Methods MEDLINE, Embase, PsycInfo, and the Cochrane Library were searched from inception to April 2023.
Manik Chhabra, Arun Paul, Omaymah Abulannaz, Mê‐Linh Lê, Holly Mansell, Yaron Finkelstein, Richard J. Huntsman, Lauren E. Kelly   +7 more
wiley   +1 more source

Killing several birds with one stone: A multi‐indication population pharmacokinetic model and Bayesian estimator for enteric‐coated mycophenolate sodium

British Journal of Clinical Pharmacology, Volume 91, Issue 5, Page 1396-1408, May 2025.
Abstract Aims Mycophenolic acid (MPA), the active component of enteric‐coated mycophenolate sodium (EC‐MPS), exhibits highly variable pharmacokinetics. Only a few population pharmacokinetic (popPK) models and Bayesian estimators (MAP‐BE) exist for estimating MPA AUC and all in renal transplantation.
Yeleen Fromage, Hamza Sayadi, Kevin Koloskoff, Pierre Marquet, Marc Labriffe, Caroline Monchaud, Jean‐Baptiste Woillard   +6 more
wiley   +1 more source

Doprinos novoga farmakovigilancijskoga zakonodavstva EU-a u zaštiti zdravlja [PDF]

, 2016
Cilj istraživanja: Cilj ovog rada bio je istražiti doseg današnje farmakovigilancije, odnosno utjecaj nove farmakovigilancijske legislative Europske unije na praćenja sigurnosnog profila lijeka, a ponajviše njezin doprinos zaštiti zdravlja pacijenta ...
Mihalić, Maša
core   +1 more source