Results 141 to 150 of about 183,249 (258)

Understanding adverse events following immunisation: evidence of vaccine safety and coincidental events from 3 years of surveillance. [PDF]

BMJ Paediatr Open
Mathew M, Sanathan SR, Ravi MD.
europepmc   +1 more source

Zimbabwe adverse events following immunisation surveillance system: A descriptive study with COVID-19 vaccine safety updates. [PDF]

S Afr J Infect Dis
Nyambayo PPM, Manyevere R, Chirinda L, Marekera SF, Nyamandi T, Chaitezvi RP, Rukwata RT, Mehta U, Gold MS.   +8 more
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

MMRV vaccine safety: A comprehensive analysis of adverse events recorded among pediatric populations. [PDF]

Hum Vaccin Immunother
Yan K, Yang G, Yan L, Wu R, Wu L, Wang Y, He P, Yu Q.   +7 more
europepmc   +1 more source

Utilization of immune checkpoint inhibitors for the treatment of cancer in Scotland, 2018–2024: A national retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of the study is to describe the use of immune checkpoint inhibitors (ICIs) for the treatment of cancer in Scotland. Methods The retrospective observational cohort study included patients aged 18 years or older who commenced treatment with an ICI in Scotland between 1 January 2018 and 31 December 2024.
Tanja Mueller, Christine Crearie, Liya Lu, Jiafeng Pan, Fraser N. Sneden, David Martin, Amanj Kurdi, Catherine S. Thomson, Julie Clarke, Marion Bennie   +9 more
wiley   +1 more source

Mapping Pediatric Seasonal Influenza Vaccine Safety and Immunogenicity Evidence: A Systematic Review of Clinical Trials. [PDF]

Vaccines (Basel)
Munoz A, Olivares B, Yepes-Perez Y, Chen Y, Ortiz J, Amin M, Zeng M.   +6 more
europepmc   +1 more source

MT‐RNR1 genotype testing for preventing aminoglycoside‐mediated ototoxicity: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

British Journal of Clinical Pharmacology, EarlyView.
Aminoglycosides are broad‐spectrum antibiotics used in the management of severe infections. Aminoglycosides are associated with nephrotoxicity and ototoxicity. Although dosing strategies such as once‐daily administration and therapeutic drug monitoring have reduced the incidence of nephrotoxicity, ototoxicity remains unpredictable and may occur at ...
John H. McDermott, Sian Hilton, Cinzia Dello Russo, Nicola Booth, Simon Drysdale, Philip Howard, Stephen Hughes, Mallinath Chakraborty, Helen McDevitt, Charlotte Alston, Maya Desai, Mike Beadsworth, Adam Reynolds, Serim Min, Katherine Payne, Munir Pirmohamed, William G. Newman   +16 more
wiley   +1 more source

Safety of COVID-19 and influenza vaccines in children and adolescents with immunocompromised or autoimmune conditions: Findings from the Canadian National Vaccine Safety (CANVAS) network. [PDF]

Hum Vaccin Immunother
Turner C, Vanderkooi OG, Kellner JD, Shulha HP, Muller MP, Sadarangani M, Isenor JE, Marty K, Soe P, Kiely M, Valiquette L, McGeer A, Bettinger JA.   +12 more
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Vaccine safety for individuals receiving immune checkpoint inhibitor therapy: A narrative review of current literature and recommendations for future research. [PDF]

Hum Vaccin Immunother
Sundaram ME.
europepmc   +1 more source