Results 141 to 150 of about 3,800 (262)

Targeting Amastigote and Trypomastigote Phases: Multi‐Epitope Vaccine Strategy Against Trypanosoma cruzi

open access: yesBiotechnology and Applied Biochemistry, EarlyView.
ABSTRACT Effective vaccines against Trypanosoma cruzi, the causative agent of Chagas disease, are urgently needed. Here, we report the design and in silico validation of a novel multiepitope vaccine construct targeting the key surface proteins ASP‐2 and gp82. Using a comprehensive immunoinformatics pipeline, we identified and selected 38 potent T‐cell (
Maria Karolaynne da Silva   +8 more
wiley   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

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

open access: yesBritish 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   +19 more
wiley   +1 more source

Semaglutide vs. liraglutide and incidence of diabetes and cardiovascular disease: A target trial emulation using real‐world data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims The glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) semaglutide and liraglutide are approved for chronic weight management. Both drugs also have favourable effects on the risk of developing diabetes and cardiovascular disease (CVD) compared with placebo, but their comparative effectiveness for these outcomes is unclear.
Ethan J. Cannon   +7 more
wiley   +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)

open access: yesBritish 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   +16 more
wiley   +1 more source

Tropes

open access: yesThe Iowa Review, 1997
openaire   +1 more source

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