Results 181 to 190 of about 116,265 (265)

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

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

open access: yesBritish 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   +9 more
wiley   +1 more source

Cause of Death and Risk of Death for People Living With HIV Admitted to Hospital: A Systematic Review and Meta-Analysis. [PDF]

open access: yesJ Int AIDS Soc
Burke RM   +11 more
europepmc   +1 more source

Impact of the pancreatic enzyme replacement therapy (PERT) shortage on prescribing in England: Analysis of national data

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Pancreatic enzyme replacement therapy (PERT) is essential for the management of pancreatic exocrine insufficiency. Since June 2023, the United Kingdom has been affected by a global shortage of PERT. We investigated the impact of this shortage on national prescribing trends for Creon, Nutrizym, Pancrex and Pangrol.
Teena S. Varghese   +6 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

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish 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   +2 more
wiley   +1 more source

Global health perspectives on diet patterns micronutrients and climato-economic factors. [PDF]

open access: yesiScience
Pan J   +8 more
europepmc   +1 more source

Pharmacogenomics of dolutegravir: A scoping review of evidence, gaps and clinical implications

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Dolutegravir underpins modern first‐ and second‐line HIV treatment regimens; however, interindividual variability in its disposition and tolerability presents challenges for optimal use. This scoping review mapped current evidence on the pharmacogenomics of dolutegravir, focusing on pharmacokinetics and pharmacodynamics, and methodological limitations ...
Ronald Kiguba   +2 more
wiley   +1 more source

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