Results 201 to 210 of about 1,007,353 (300)

The impact of COVID-19 on general vaccine acceptance in low- and middle-income countries: a systematic review. [PDF]

Front Public Health
Lihemo G, Blunt M, Dadari I, Underwood T, Ochoa Toasa AE, Velias A, Hopkins KL, Thomson A, Kanwagi R, Gillespie A, Pokharel DR, Singh S.   +11 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

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

Medicines, misinformation and machines: Navigating infodemics in the generative AI era

British Journal of Clinical Pharmacology, EarlyView.
Health information is now widely accessed through smartphones, online searches and increasingly through generative artificial intelligence (AI). These systems create new opportunities for communication, and in some routine contexts, well‐governed AI assistants could reduce exposure to lower quality sources by providing cautious, evidence‐aligned ...
Natansh D. Modi, Lisa M. Kalisch Ellett, Michael D. Wiese, Ashley M. Hopkins   +3 more
wiley   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Uncovering COVID-19 vaccine acceptance and intent in 15 developing countries: a multi-level, clustered analysis of six months of repeated, cross-sectional data. [PDF]

BMC Infect Dis
Smith CA, Handysides D, Cupino A, Nelson A, Beeson WL.   +4 more
europepmc   +1 more source

Health economic considerations for pharmacogenomic services in the United Kingdom: The Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics

British Journal of Clinical Pharmacology, EarlyView.
Dyfrig A. Hughes, Henry Fong, Grace Hampson, Catrin O. Plumpton, Chris Sampson   +4 more
wiley   +1 more source

Pharmacokinetics and safety of a modified‐release psilocybin formulation: A SAD Phase I trial in normal‐weight and overweight/obese participants

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified‐release psilocybin formulation (REL‐P11) in normal‐weight and overweight/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic ...
Anna Signor, Stefano Comai, Gianfranco Pasut, Franco Folli, Marco Gentilucci, Negar Gharavi, Sofia Raitsin, Thuy Van Nguyen, Marco Pappagallo, Andrea Mattarei, Paolo L. Manfredi, Sara De Martin   +11 more
wiley   +1 more source

Analysis of regulatory review models and approval timelines across selected African medicines regulatory authorities using the OpERA framework (2020–2024)

British Journal of Clinical Pharmacology, EarlyView.
Background The World Health Organization (WHO) developed the Global Benchmarking Tool (GBT) to assess national regulatory systems and support regulatory‐system strengthening across regulatory functions. Several African National Medicines Regulatory Authorities (NMRAs) have achieved Maturity Level 3 (ML3).
Constance Sakala Chisha, Stephanie Leigh, Makomani Siyanga, Grace Matimba, Richard Rukwata, Mercy Owusu‐Asante, Kwabena Frimpong‐Manso Opuni, Pratibha Sobrun, Boitumelo Semete‐Makokotlela, Adem Kermad, Stuart Walker   +10 more
wiley   +1 more source

Validation of Health Belief Model and Theory of Planned Behaviour Constructs for Predicting Malaria Vaccine Acceptance in Ghana: A Partial Least Squares Structural Equation Modelling Approach. [PDF]

Trop Med Int Health
Sarfo M, Snowden M, Halsall JP.
europepmc   +1 more source