Results 81 to 90 of about 3,041 (213)

The lack of legal protections in the United States to prevent commercializing the dead for education and research: Consequences and risks to anatomists

Anatomical Sciences Education, EarlyView.
Abstract A lack of minimum legal standards for body donation programs undermines recent strides by anatomy professionals to promote ethical best practices in the United States (US). In particular, the commercialization of the dead by nontransplant tissue banks poses a risk to the public trust in academic body donation programs.
Laura E. Johnson
wiley   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

British Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner, Daniela Krepper, Micha Johannes Pilz, Lisa Marie Storz, Maike Thumfart, Johannes Maria Giesinger   +5 more
wiley   +1 more source

Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib

British Journal of Clinical Pharmacology, EarlyView.
Aim Small‐molecule activin receptor‐like kinase‐2 inhibitor zilurgisertib (INCB000928) is under investigation in a pivotal trial for the treatment of fibrodysplasia ossificans progressiva (FOP), an ultrarare genetic condition. This analysis assessed effects of renal and hepatic impairment on zilurgisertib pharmacokinetics.
Yan‐ou Yang, Yunlan Fang, Phillip Wang, Xiang Liu, Jay Getsy, Kevin Rockich   +5 more
wiley   +1 more source

An open‐label, single‐arm, dose‐escalating concentration–QT study to investigate the cardiac effects and safety of paroxetine in healthy adults

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Paroxetine is a selective serotonin reuptake inhibitor (SSRI), approved for treatment of major depressive disorder and anxiety disorders. Some SSRIs are known to prolong the QT interval; however, clinical evidence to establish a lack of association between paroxetine and corrected QT interval (QTc) prolongation is limited. Therefore, this
Sven C. van Dijkman, Mathieu Félices, Bhaskar Pandurangavittal, Sanman Ghorpade, Caroline Easterbrook, Marcin Zabielski, Oscar Della Pasqua   +6 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

Europe at the Time of Implementation of International Accounting Standards in the Context of International Accounting Harmonisation

, 2004
The article intends to explain the process of implementation of International Accounting Standards by the European Union. This process is presented in the context of international globalization of capital and goods markets. The author discusses the role of the European Union itself in the process of harmonization of accounting and the role of ...
openaire   +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

Analysis of interstitial lung disease in pharmacovigilance databases: Coding challenges and interpretation biases—An update

British Journal of Clinical Pharmacology, EarlyView.
Aim Clinically, interstitial lung disease (ILD) is a heterogeneous group of respiratory disorders. Due to their low incidence, pharmacovigilance database analysis is useful to detect them. Precise diagnosis is challenging as well as coding in these databases. Query criteria are among the key elements for a good signal detection.
Romane Freppel, Adeline Benis, Philippe Bonniaud, Jean‐Luc Faillie, Aurélie Grandvuillemin   +4 more
wiley   +1 more source

Prospective Open-Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke. [PDF]

Brain Behav
Sabellano ZF, Pedregosa B, Batino LK, Navarro J.   +3 more
europepmc   +1 more source