Results 101 to 110 of about 6,306 (210)
Context Engineering for AI‐Assisted Pharmacometrics: A Practical Tutorial
ABSTRACT Large language models can execute pharmacometric workflows, but they make consequential domain‐specific errors when task instructions lack adequate details. This tutorial teaches pharmacometricians how to define self‐contained tasks that embed domain‐specific rules, verification criteria, and worked examples into each step of a pharmacometric ...
Ari Pritchard‐Bell +3 more
wiley +1 more source
ABSTRACT Physiologically based pharmacokinetic (PBPK) modeling is increasingly used to predict infant exposure to medications via breast milk. Existing guidance on reporting of PBPK modeling analyses is unstructured and nonbinding to researchers. We evaluated reporting practices and modeling approaches in published PBPK modeling studies.
Joshua Kiptoo +8 more
wiley +1 more source
ABSTRACT Objective Bipolar disorder (BD) often emerges during mid‐adolescence and young adulthood, and leads to functional and social impairment, with a prevalence of 0.87% among Dutch youth. Lithium, the first‐line BD maintenance treatment, stabilizes mood, prevents suicide, and is well tolerated, yet its use has declined as long‐term second ...
Ravish N. Gangapersad +8 more
wiley +1 more source
Pharmacometrics and/or Systems Pharmacology [PDF]
openaire +3 more sources
ABSTRACT Bridging studies are often waived for orphan diseases such as multiple myeloma (MM) due to challenges in conducting clinical trials in small and heterogeneous populations. However, demographic and regional differences between trial participants and Asian populations may influence drug exposure and response.
Minji Kang +4 more
wiley +1 more source
Data‐driven disease progression model of Parkinson's disease and effect of sex and genetic variants
As Parkinson's disease (PD) progresses, there are multiple biomarker changes, and sex and genetic variants may influence the rate of progression. Data‐driven, long‐term disease progression model analysis may provide precise knowledge of the relationships
Ryota Jin +3 more
doaj +1 more source
Tutorial on Analyzing Patient‐Reported Outcome Measures in Clinical Development
ABSTRACT Patient‐reported outcomes (PROs) are now considered essential components of clinical development and regulatory assessment. Despite their widespread collection, PRO data remain under‐utilized, with analyses often limited to descriptive summaries or single time‐point comparisons that fail to capture the richness, longitudinal structure, and ...
Krina Mehta +4 more
wiley +1 more source
Deep‐Learning: An Emerging Tool to Support Model‐Informed Drug Development
ABSTRACT Traditional Model‐Informed Drug Development (MIDD) primarily relies on hypothesis‐driven (HD) models based on biological, physiological, and physicochemical principles. While these mechanistic models have been instrumental in drug development and regulatory decision‐making, they may be limited in capturing complex nonlinear relationships. Deep
Roberto Gomeni +1 more
wiley +1 more source
Efficacy and safety of ibrutinib 560 mg once daily or placebo combined with bendamustine and rituximab (BR) were assessed in patients with mantle cell lymphoma in a randomized phase 3 study (SHINE).
Per Olsson Gisleskog +5 more
doaj +1 more source
A workflow for appying pharmacometrics‐enable machine learning analysis to predict 2‐month culture conversion using phase 2a data. ABSTRACT Phase 2a trials in tuberculosis patients traditionally assess early bactericidal activity over two weeks, often using the time‐to‐positivity biomarker, followed by a phase 2b study typically lasting 8‐week with ...
Huifang You, Ulrika S. H. Simonsson
wiley +1 more source

