Results 221 to 230 of about 1,047,469 (289)

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

Age‐related differences in hydroxychloroquine‐associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System

British Journal of Clinical Pharmacology, EarlyView.
Aims This real‐world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004–2024) to characterize age‐related disparities in hydroxychloroquine (HCQ)‐associated adverse events (AEs), addressing gaps in age‐stratified risk assessment. Methods Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull
Guanghan Sun, Jingrong Yang, Lei Wan, Xia Xu, Jing Wang   +4 more
wiley   +1 more source

Reducing Domestic Wood Burning through Voluntary Air Quality Alerts: An IBM-WASH Evaluation of a Pilot Intervention in Wales. [PDF]

Environ Manage
Heydon J, Price M, Walker I, Lewis P, Chakraborty R, Bunce C, Sunter K.   +6 more
europepmc   +1 more source

Invitation to Explanation of Voluntary Tax Compliance

, 2019
openaire   +2 more sources

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari, Caroline S. Copeland, Georgia C. Richards   +2 more
wiley   +1 more source

When imitation meets exploration: quantifying social efficiency deficits (SED) in vaccination behaviour. [PDF]

J R Soc Interface
Srivastav AK, Shen C, Tanimoto J.
europepmc   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Multimodal Prodromal Patterns Associated with COPD Exacerbations in Home Telemonitoring: An Exploratory Observational Study. [PDF]

Bioengineering (Basel)
Sanchez-Morillo D, Camacho-Magriñán P, León-Jiménez A.   +2 more
europepmc   +1 more source

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end‐point was submission type.
Andrea Manfrin, Mark Grumbridge, Daniel Hill, Crina Cacou, Graham Warren, James Pound, Jacob George, Alejandro F. Frangi   +7 more
wiley   +1 more source

Effectiveness of small-quantity versus medium-quantity lipid-based nutrient supplements for prevention of undernutrition in young children: protocol for an individually randomised, parallel-group, non-inferiority trial. [PDF]

BMJ Open
Ariff S, Alam R, Chauhdary IA, Muhammad S, Khan GN, Maznani I, Wali N, Muhammad S, Ghaffar A, Ihtesham Y, Badar A, Raza A, Ijaz A, Rana R, de Pee S, Soofi S, Bhutta ZA.   +16 more
europepmc   +1 more source