Results 61 to 70 of about 12,447 (257)

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

Population Physiologically‐Based Pharmacokinetic Modeling to Determine Ontogeny: A Quantitative Clinical Pharmacology Example in Pediatric Rare Disease

CPT: Pharmacometrics & Systems Pharmacology
Pediatric physiologically‐based pharmacokinetic (PBPK) modelling plays an increasing role in selecting doses in children and addressing clinical pharmacology questions.
Yumi Cleary, Bhagwat Prasad, Kayode Ogungbenro, Michael Gertz, Aleksandra Galetin   +4 more
doaj   +1 more source

The quantitative impact of metabolism‐inhibiting drugs on the occurrence of adverse drug reactions—A backward selection approach

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The quantitative effect of several inhibitory drugs on the development of adverse drug reactions (ADRs) is currently difficult to estimate. Our aim was to identify metabolic pathways, which, when inhibited, increase the risk for certain ADRs, and to use this system to consider comedication at individual level. Methods Data of a prospective
Judith Berres, Justyna Wozniak, Hannah Fölsch, Anja Knueppel‐Ruppert, Verena Graeff, Andrea Kriegisch‐Stumpf, Harald Dormann, Julia C. Stingl, Katja S. Just   +8 more
wiley   +1 more source

Applied Concepts in PBPK Modeling: How to Extend an Open Systems Pharmacology Model to the Special Population of Pregnant Women

CPT: Pharmacometrics & Systems Pharmacology, 2018
This tutorial presents the workflow of adapting an adult physiologically based pharmacokinetic (PBPK) model to the pregnant populations using the Open Systems Pharmacology (OSP) software suite (www.open-systems-pharmacology.org).
André Dallmann, Juri Solodenko, Ibrahim Ince, Thomas Eissing   +3 more
doaj   +1 more source

Complex Mixtures: Array PBPK Modeling of Jet Fuel Components

Toxics, 2023
An array physiologically-based pharmacokinetic (PBPK) model represents a streamlined method to simultaneously quantify dosimetry of multiple compounds. To predict internal dosimetry of jet fuel components simultaneously, an array PBPK model was coded to simulate inhalation exposures to one or more selected compounds: toluene, ethylbenzene, xylenes, n ...
Teresa R. Sterner, Tammie R. Covington, David R. Mattie   +2 more
openaire   +3 more sources

Cardiovascular‐Kidney‐Metabolic Syndrome in People With HIV: An Emerging Frontier for Clinical Pharmacology

Clinical Pharmacology &Therapeutics, EarlyView.
As antiretroviral therapy (ART) prolongs lifespans, people with HIV (PWH) face a new syndemic: Cardiovascular‐Kidney‐Metabolic (CKM) syndrome. Yet CKM in PWH is poorly characterized. Inflammation, complex pharmacokinetic (PK) alterations, ART‐associated metabolic effects, and gut dysbiosis amplify risk. Managing CKM increases medication burden, thereby
Aaron S. Devanathan, Thomas D. Nolin
wiley   +1 more source

Interspecies evaluation of a physiologically based pharmacokinetic model to predict the biodistribution dynamics of dendritic nanoparticles.

PLoS ONE, 2023
The exposure of a dendritic nanoparticle and its conjugated active pharmaceutical ingredient (API) was determined in mouse, rat and dog, with the aim of investigating interspecies differences facilitating clinical translation.
Christina Vasalou, Joanna Harding, Rhys D O Jones, Niresh Hariparsad, Dermot F McGinnity   +4 more
doaj   +1 more source

Building Pharmacoequity through Student and Trainee Education, Service, and Global Outreach

Clinical Pharmacology &Therapeutics, EarlyView.
Students and trainees are integral to clinical pharmacology, as they have the potential to shape the field. This perspective highlights how the ASCPT Student and Trainee Community engages members worldwide, providing opportunities and resources to advance scientific and professional development.
Chazmyn Riley, Natasha Desiree Casas, Patricia D. Maglalang, Hongyu Su, An Le, Shravani Etrouth, Shayna R. Killam, MaryPeace McRae   +7 more
wiley   +1 more source

PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing

Clinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost‐effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory ...
Shakir Atoyebi, Prajith Venkatasubramanian, Abdulafeez Akinloye, Oluwasegun Eniayewu, Brookie M. Best, Laura Else, Adeniyi Olagunju   +6 more
wiley   +1 more source

Integrated PBPK-EO modeling of osimertinib to predict plasma concentrations and intracranial EGFR engagement in patients with brain metastases

Scientific Reports
The purpose of this study was to develop and validate a physiologically based pharmacokinetic (PBPK) model combined with an EGFR occupancy (EO) model for osimertinib (OSI) to predict plasma trough concentration (Ctrough) and the intracranial time-course ...
Feng Liang, Yimei Zhang, Qian Xue, Xiaoling Zhang   +3 more
doaj   +1 more source