Results 191 to 200 of about 501,679 (264)
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
British Journal of Clinical Pharmacology, EarlyView.Aims In medical education, the ability of large language models (LLMs) to match human performance raises questions about their potential as educational tools. This study evaluates LLMs' performance on Clinical Pharmacology and Therapeutics (CPT) exams, comparing their results to medical students and exploring their ability to identify poorly formulated
Alexandre O. Gérard +11 more
wiley +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 +5 more
wiley +1 more source
How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
British Journal of Clinical Pharmacology, EarlyView.The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley +1 more source
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 +3 more
wiley +1 more source
1974 SUGGESTED STATE LEGISLATION
, 1973 Council of State Governments. Committee on Suggested State Legislation
core
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 +4 more
wiley +1 more source
Developing medication independence: The experience of UK teenagers
British Journal of Clinical Pharmacology, EarlyView.Aims There is a progression through childhood from being provided medications by caregivers to having to take responsibility for medications yourself, but little is known about when the transition of adolescents managing medicines begins. The aim of this study was to obtain a cross‐sectional sample of UK adolescents and when they become independent ...
Holly Hutchins +5 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Aims We studied the prevalence of psychotropic use and psychotropic polypharmacy in persons with Parkinson's disease (PD) during a 10‐year follow‐up, because longitudinal studies on this topic are scarce although non‐motor symptoms of PD are often treated with psychotropics.
Noora Nieminen +4 more
wiley +1 more source
Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe
British Journal of Clinical Pharmacology, EarlyView.Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis +4 more
wiley +1 more source