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Machine learning approaches for assessing medication transfer to human breast milk
Machine learning approaches for assessing medication transfer to human breast milk
The human milk/plasma (M/P) drug concentration ratio is crucial in pharmacology, especially for breastfeeding mothers unde...
Predicting tumor dynamics in treated patients from patient-derived-xenograft mouse models: a translational model-based approach
Predicting tumor dynamics in treated patients from patient-derived-xenograft mouse models: a translational model-based approach
This study presents a translational modeling framework designed to predict tumor size dynamics in cancer patients undergoi...
Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables
Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables
To evaluate the role of diffusion process dimensionality in drug absorption following subcutaneous or intramuscular admini...
Stochastic pharmacodynamics of a heterogeneous tumour-cell population
Stochastic pharmacodynamics of a heterogeneous tumour-cell population
Standard pharmacodynamic models are ordinary differential equations without the features of stochasticity and heterogeneit...
Informatics for toxicokinetics
Informatics for toxicokinetics
Toxicokinetic and pharmacokinetic (PK) summary parameters, such as Cmax (peak concentration), AUC (time-integrated area un...
A translational physiologically-based pharmacokinetic model for MMAE-based antibody-drug conjugates
A translational physiologically-based pharmacokinetic model for MMAE-based antibody-drug conjugates
The objective of this work was to develop a translational physiologically-based pharmacokinetic (PBPK) model for antibody-...
Leveraging large language models to compare perspectives on integrating QSP and AI/ML
Leveraging large language models to compare perspectives on integrating QSP and AI/ML
Two recent papers offer contrasting perspectives on integrating Quantitative Systems Pharmacology (QSP) and Artificial Int...
Beyond the linear model in concentration-QT analysis
Beyond the linear model in concentration-QT analysis
The white-paper regression model is the standard method for assessing QT liability of drugs. The quantity of interest, pla...
A comprehensive review of 20 years of progress in nonclinical QT evaluation and proarrhythmic assessment
A comprehensive review of 20 years of progress in nonclinical QT evaluation and proarrhythmic assessment
The assessment of drug-induced QT interval prolongation and associated proarrhythmic risks, such as Torsades de Pointes (T...
Interplay between pharmacokinetics and immunogenicity of therapeutic proteins: stepwise development of a bidirectional joint pharmacokinetics-anti-drug antibodies model
Interplay between pharmacokinetics and immunogenicity of therapeutic proteins: stepwise development of a bidirectional joint pharmacokinetics-anti-drug antibodies model
The aim of the analysis was to develop a phenomenological longitudinal population pharmacokinetics (PK)-anti-drug antibodi...
Leveraging large language models in pharmacometrics: evaluation of NONMEM output interpretation and simulation capabilities
Leveraging large language models in pharmacometrics: evaluation of NONMEM output interpretation and simulation capabilities
Advancements in large language models (LLMs) have suggested their potential utility for diverse pharmacometrics tasks. Thi...
Cross-species translational modelling of targeted therapeutic oligonucleotides using physiologically based pharmacokinetics
Cross-species translational modelling of targeted therapeutic oligonucleotides using physiologically based pharmacokinetics
Oligonucleotide therapeutics hold promise for targeted gene silencing, yet achieving optimal tissue-specific delivery rema...
The dawn of a new era: can machine learning and large language models reshape QSP modeling?
The dawn of a new era: can machine learning and large language models reshape QSP modeling?
Quantitative Systems Pharmacology (QSP) has emerged as a cornerstone of modern drug development, providing a robust framew...
FDA's insights: implementing new strategies for evaluating drug-induced QTc prolongation
FDA's insights: implementing new strategies for evaluating drug-induced QTc prolongation
The questions and answers (Q&A) document for ICH E14/S7B provides the following advancements for QTc assessment: c...
Using Fisher Information Matrix to predict uncertainty in covariate effects and power to detect their relevance in Non-Linear Mixed Effect Models in pharmacometrics
Using Fisher Information Matrix to predict uncertainty in covariate effects and power to detect their relevance in Non-Linear Mixed Effect Models in pharmacometrics
This work focuses on design of experiments for Pharmacokinetic (PK) and Pharmacodynamic (PD) studies. Non-Linear Mixed Eff...
Physiologically-based pharmacokinetic model for predicting drug-drug interactions perpetrated by posaconazole in healthy subjects with normal weight and obesity: Concomitant use and washout
Physiologically-based pharmacokinetic model for predicting drug-drug interactions perpetrated by posaconazole in healthy subjects with normal weight and obesity: Concomitant use and washout
Posaconazole is an effective broad-spectrum triazole antifungal used as prophylaxis or to treat invasive Aspergillus and C...
Identification of oncology pharmacokinetic drivers through in vitro experiments and computational modeling
Identification of oncology pharmacokinetic drivers through in vitro experiments and computational modeling
Drug discovery balances many factors as it identifies compounds for clinical testing, including compound efficacy, safety,...
A semi-mechanistic population pharmacokinetic-pharmacodynamic model to assess downstream drug-target effects on erythropoiesis
A semi-mechanistic population pharmacokinetic-pharmacodynamic model to assess downstream drug-target effects on erythropoiesis
Erythropoiesis is a complex process that results in the production of erythrocytes from hematopoietic stem cells in the bo...
Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progression
Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progression
Autosomal dominant tubulointerstitial kidney disease (ADTKD), caused by mutations in UMOD and MUC1 genes, leads to tubular...
Practical guide to concentration-QTc modeling: a hands-on tutorial
Practical guide to concentration-QTc modeling: a hands-on tutorial
Concentration-QTc (C-QTc) analysis is a model-based method widely used to assess the impact of drugs on QT interval durati...
A quantitative modeling framework to understand the physiology of the hypothalamic-pituitary-adrenal axis and interaction with cortisol replacement therapy
A quantitative modeling framework to understand the physiology of the hypothalamic-pituitary-adrenal axis and interaction with cortisol replacement therapy
Congenital adrenal hyperplasia (CAH) is characterized by impaired adrenal cortisol production. Hydrocortisone (synthetic c...
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Quantitative predictive modeling of cancer growth, progression, and individual response to therapy is a rapidly growing fi...
Population pharmacokinetics and exposure–response relationships of maribavir in transplant recipients with cytomegalovirus infection
Population pharmacokinetics and exposure–response relationships of maribavir in transplant recipients with cytomegalovirus infection
Maribavir is approved for management of post-transplant cytomegalovirus (CMV) infections refractory and/or resistant to CM...
pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization
pyDarwin machine learning algorithms application and comparison in nonlinear mixed-effect model selection and optimization
Forward addition/backward elimination (FABE) has been the standard for population pharmacokinetic model selection (PPK) si...
An asymptotic description of a basic FcRn-regulated clearance mechanism and its implications for PBPK modelling of large antibodies
An asymptotic description of a basic FcRn-regulated clearance mechanism and its implications for PBPK modelling of large antibodies
A basic FcRn-regulated clearance mechanism is investigated using the method of matched asymptotic expansions. The broader ...
In memory of Dr. Thomas M. Ludden: a pioneer in pharmacometrics, a mentor to many, and a legacy of compassionate science
In memory of Dr. Thomas M. Ludden: a pioneer in pharmacometrics, a mentor to many, and a legacy of compassionate science
Cite this articleRiley, S., Korth-Bradley, J., Bauer, R.J. et al. In memory of Dr. Thomas M. Ludden: a pioneer in pharmaco...
Virtual clinical trials via a QSP immuno-oncology model to simulate the response to a conditionally activated PD-L1 targeting antibody in NSCLC
Virtual clinical trials via a QSP immuno-oncology model to simulate the response to a conditionally activated PD-L1 targeting antibody in NSCLC
Recently, immunotherapies for antitumoral response have adopted conditionally activated molecules with the objective of re...
Population pharmacokinetic analyses of pozelimab in patients with CD55-deficient protein-losing enteropathy (CHAPLE disease)
Population pharmacokinetic analyses of pozelimab in patients with CD55-deficient protein-losing enteropathy (CHAPLE disease)
Pozelimab, a monoclonal antibody directed against C5, is the first and only treatment for adult and pediatric patients (&#...
Visual predictive check of longitudinal models and dropout
Visual predictive check of longitudinal models and dropout
Visual predictive checks (VPC) are commonly used to evaluate pharmacometrics models. However their performance may be hamp...
Time Scale Calculus: a new approach to multi-dose pharmacokinetic modeling
Time Scale Calculus: a new approach to multi-dose pharmacokinetic modeling
In this paper, we use Time Scale Calculus (TSC) to formulate and solve pharmacokinetic models exploring multiple dose dyna...
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