Results 71 to 80 of about 31,766 (260)

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

British Journal of Clinical Pharmacology, EarlyView.
Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

British Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson, Helen Dolk, Maria Loane, Christine Damase‐Michel, Joanne Given, Hedvig Nordeng, Jorieke E. H. Bergman, Iain Carey, Elly Den Hond, Ester Garne, Florence Rouget, Lea Bruneau, Isabelle Monier, Anke Rissmann, Mary O'Mahony, Miriam Gatt, Renée Lutke, Joanna Sichitiu, Elisa Ballardini, Alessio Coi, Clara Cavero Carbonell, David Tucker, Joan Morris   +22 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

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines

BMC Medicine, 2017
Background The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear.
Priya Bahri, Julianna Fogd, Daniel Morales, Xavier Kurz, on behalf of the ADVANCE consortium   +4 more
doaj   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

British Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus, Johaina Sarrage, Hilde Samdal, François Montastruc, Elena Rocca   +4 more
wiley   +1 more source

Applying machine learning to pharmacovigilance data: A proof‐of‐concept study

British Journal of Clinical Pharmacology, EarlyView.
Aim Machine learning (ML) applications in pharmacovigilance remain limited and underexplored. Using data from the French National pharmacovigilance database (FNPV), this proof‐of‐concept study aimed to assess the feasibility of using a ML algorithm—eXtreme Gradient Boosting (XGBoost)—combined with SHapley Additive exPlanations (SHAP) analysis, to ...
Romain Barus, Pauline Schiro, Jean‐Luc Faillie, Romane Freppel, Johana Béné, Claire de Canecaude, François Montastruc   +6 more
wiley   +1 more source

A descriptive case series of hepatotoxicity associated with CFTR modulators and possible relevance of pharmacogenetic polymorphisms in cystic fibrosis patients

British Journal of Clinical Pharmacology, EarlyView.
Cystic fibrosis transmembrane conductance regulator (CFTR) modulators are widely used in patients with cystic fibrosis and significantly improve respiratory function and quality of life. However, their effectiveness may be limited by liver damage, which sometimes leads to treatment discontinuation, and the mechanisms underlying this remain poorly ...
Clara Laffitte Redondo, Venceslas Bourdin, Abd El Kader Ait Tayeb, Sihem Benaboud, Inès Martins, Caroline Joyau, Myriam Benhamida, Isabelle Sermet‐Gaudelus, Clémence Martin, Pierre Régis Burgel, Céline Verstuyft, Laurent Chouchana, Estelle Ayme‐Dietrich   +12 more
wiley   +1 more source

Cardiovascular and neuropsychiatric outcomes with PCSK9 inhibitors in atherosclerotic cardiovascular disease: A retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Study design and main findings. After 1:1 propensity score matching, 60 885 PCSK9 inhibitor users and 60 885 statin‐only users with ASCVD were compared. Kaplan–Meier curves show 12‐month cumulative event‐free survival for MACE, psychiatric disease, and neurodegenerative disease.
Tianshu Gu, Yang Chen, Nan Zhang, Uazman Alam, Riccardo Proietti, Tong Liu, Kang‐Yin Chen, Gregory Y. H. Lip   +7 more
wiley   +1 more source

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