Results 151 to 160 of about 261,789 (293)

Awareness of the Black Triangle Scheme among healthcare professionals and consumers in Australia: A mixed‐methods study exploring reporting intentions and suggested improvements

British Journal of Clinical Pharmacology, EarlyView.
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes, Sieta T. de Vries, Mohammed Gebre Dedefo, Oliver Frank, Myra Thiessen, Lisa Kalisch Ellett, Christopher Thornton, Renly Lim   +7 more
wiley   +1 more source

First‐in‐human, phase I, randomized, safety, pharmacokinetic, food‐effect and pharmacodynamic study of a tyrosine kinase 2/Janus kinase 1 inhibitor, SDC‐1801

British Journal of Clinical Pharmacology, EarlyView.
Aim The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), food‐effect (FE) and pharmacodynamics (PD) of an oral tyrosine kinase‐2 (TYK2)/Janus kinase‐1 (JAK1) inhibitor, SDC‐1801, in healthy adult participants. Methods This first‐in‐human study randomized 95 male and female participants.
Chris Brearley, Sam Francis, John Reader, Judi Proctor   +3 more
wiley   +1 more source

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

British Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus, Johaina Sarrage, Hilde Samdal, François Montastruc, Elena Rocca   +4 more
wiley   +1 more source

Criminal Procedure: Medical and Scientific Evidence: Secondary Legislation [PDF]

The advantage of secondary legislation is that it is more flexible than primary legislation. Changes in practice and procedure or innovations in e.g. medical and scientific evidence techniques can be accommodated by small changes to egulations rather ...
Allen, Andrew
core  

From understanding to agreement: The current state of informed consent in Nigerian endoscopic practice. [PDF]

World J Methodol
Okonkwo KC, Davwar PM, Musa Y, Bojuwoye MO, Onyia CP, Egboh SC, Chukwurah SN, Obasi E, Asaolu OI, Adiri WN, Okeke UF, Dankiri NA, Udigwe CF.   +12 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

Global pMDI Use and the Potential Impact of European PFAS Legislation on Access to These Essential Inhaled Medications. [PDF]

Pulm Ther
Kocks JWH, Harrison T, Bell JP, Rignall A, Khezrian M, Usmani OS.   +5 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

Medical device development and innovation for rare and pediatric populations: a global landscape overview. [PDF]

Orphanet J Rare Dis
Dooms M, O'Connor D, Melvin T, Mueller F, Peiris V, Pohlson K, Wong-Rieger D, Jonker AH, IRDiRC WG Medical Technologies for Rare Diseases.   +8 more
europepmc   +1 more source