Results 91 to 100 of about 100,679 (216)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

British Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Perceptions of dietitians and key role players regarding their role in reporting food labelling transgressions in South Africa

The South African Journal of Clinical Nutrition
Objectives: A study was undertaken to describe South African dietitians and key role players’ perceptions regarding their role in reporting food labelling legislation transgressions.Design: A multimethod study design was employed to explore a previously ...
M Profe-Fuchsloch, N Koen, M Wicks
doaj   +1 more source

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

British Journal of Clinical Pharmacology, EarlyView.
Abstract This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders.
Justin L. Hay, Amandine Manon, Hunter Stephens, S. Y. Amy Cheung, Bart de Keizer, Erik T. te Beek   +5 more
wiley   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 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

Listening to Hong Kong children's perspectives through pretend play

British Educational Research Journal, EarlyView.
Abstract Quality in early childhood education and care (ECEC) has become an increasing concern in recent years. The issue has been regularly discussed by different stakeholders. However, the rising concern regarding quality in ECEC has not seriously taken into account children's perspectives.
Suzannie K. Y. Leung
wiley   +1 more source

Bridging home, school and community to address educational inequality: Supporting educational trajectories through community bridge work

British Educational Research Journal, EarlyView.
Abstract This paper explores the role of community stakeholders in supporting the educational trajectories of students experiencing socio‐economic disadvantage in the Irish context. Building on international and national policy debates, the study examines how community‐based organisations, statutory services and outreach initiatives work alongside ...
Aoife Joy Keogh, Deirdre McGillicuddy
wiley   +1 more source

Hong Kong's non‐local undergraduate recruitment: Policies, institutional practices and student perspectives

British Educational Research Journal, EarlyView.
Abstract Beneath the Hong Kong government's enthusiasm for recruiting non‐local undergraduates—including students from the Chinese Mainland and other international regions—lies a longstanding gap in understanding the core meanings and drivers shaping the territory's expanding focus on inward international student mobility (ISM).
Fang Gao, Wei Yan Xiong, Hei‐hang Hayes Tang, Xiao Han   +3 more
wiley   +1 more source