Results 131 to 140 of about 2,930 (252)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Reconsidering the Transgender Persons (Protection of Rights) Amendment Bill, 2026: Mental Health Implications of a Regressive Shift. [PDF]

Ann Neurosci
Sahoo S, Kar SK.
europepmc   +1 more source

Acute toxicity of ADB‐CHMINACA ‐ a case series of patients with pronounced central nervous symptoms including the posterior reversible encephalopathic syndrome

British Journal of Clinical Pharmacology, EarlyView.
Aim This report presents a series of 16 patients who were admitted to the emergency department following confirmed intake of the potent synthetic cannabinoid ADB‐CHMINACA. Methods The cases are drawn from a prospective observational study following the recreational use of synthetic cannabinoids.
Maren Hermanns‐Clausen, Michaela Sommer, Annette Zschiesche, Verena Angerer, Martin Scheu, Florian Eyer, Johannes Nadler, Volker Auwärter   +7 more
wiley   +1 more source

If abortion substantially risks homicide, it should be illegal. [PDF]

Theor Med Bioeth
Braddock M.
europepmc   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Exploring the moral status of cadavers through artificial intelligence: a thematic analysis of AI-based perspectives in anatomy education. [PDF]

Philos Ethics Humanit Med
Topcu I, Karip B, Demir P, Kac B.
europepmc   +1 more source

Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Background Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under‐reporting remains widespread. We tested a novel method to increase reporting of ADR‐related hospitalizations.
Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar Luzius Hug, Thomas Stammschulte, Patrick E. Beeler   +7 more
wiley   +1 more source

Fetal rights from Islamic and contemporary legal perspectives: a scoping review. [PDF]

Reprod Health
Kakrodi SP, Sighaldeh SS, Mosadeghrad MA, Abbassi M.   +3 more
europepmc   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source