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Pharmacometric modeling with the zero-order hold
Pharmacometric modeling with the zero-order hold
Solving models comprised of nonlinear differential equations (DEs) in NONMEM using ADVAN6 or ADVAN13 typically requires su...
Characterization of CAR-T cellular kinetics and efficacy in solid tumor patients with and without prior lymphodepletion chemotherapy using a PBPK-PD model
Characterization of CAR-T cellular kinetics and efficacy in solid tumor patients with and without prior lymphodepletion chemotherapy using a PBPK-PD model
Despite tremendous clinical responses and patient benefit in hematological malignancies, chimeric Antigen Receptor (CAR) T...
An automated pipeline to generate initial estimates for population Pharmacokinetic base models
An automated pipeline to generate initial estimates for population Pharmacokinetic base models
Nonlinear mixed-effects models rely on adequate initial parameter estimates for efficient parameter optimization. Poor ini...
QT interval prolongation: clinical assessment, risk factors and quantitative pharmacological considerations
QT interval prolongation: clinical assessment, risk factors and quantitative pharmacological considerations
Prolongation of the QT interval in the ECG is a critical finding that signifies an extended duration from the onset of ven...
A note on phase I interleaved versus parallel group ascending dose designs for concentration-QTc analyses
A note on phase I interleaved versus parallel group ascending dose designs for concentration-QTc analyses
PK-QTc analyses are an integral part of drug development programs. These analyses are often based on phase I study data, a...
On the coupling between a basic FcRn mechanism and target-mediated disposition of antibodies
On the coupling between a basic FcRn mechanism and target-mediated disposition of antibodies
Understanding the pharmacokinetics of therapeutic antibodies often requires a detailed investigation of the mechanisms gov...
Identification and characterization of virtual sub-populations through phenotype-guided filtering. The challenging case of nonidentifiable models in the context of therapeutic evaluation
Identification and characterization of virtual sub-populations through phenotype-guided filtering. The challenging case of nonidentifiable models in the context of therapeutic evaluation
The usefulness of mathematical modeling of biological systems and their responses to exogenous products is now well recogn...
Aggregate data modelling: A fast implementation for fitting pharmacometrics models to summary-level data in R
Aggregate data modelling: A fast implementation for fitting pharmacometrics models to summary-level data in R
Pharmacometric modelling is traditionally performed using individual level data. Recently a new method was developed to fi...
Catalyzing change in MID3 through globalization, education, and innovation
Catalyzing change in MID3 through globalization, education, and innovation
The landscape of pharmaceutical research and drug development is undergoing a significant evolution, with Model-Informed D...
Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on phase I data
Risks encountered when not adjusting for diurnal variation and food effect in QTcF analysis based on phase I data
Phase I single and multiple ascending dose studies are more and more often used to evaluate QT liability of new drugs. How...
Concentration response analyses for QT data with several active compounds
Concentration response analyses for QT data with several active compounds
PK-QTc analyses are routinely done as part of most drug development programs. Usually, the PK concentration of a single co...
A mechanistic pharmacokinetic-pharmacodynamic model for degrader-antibody conjugates
A mechanistic pharmacokinetic-pharmacodynamic model for degrader-antibody conjugates
Degrader-antibody conjugates (DACs) represent an emerging class of innovative therapeutics that combine the unique deliver...
Simulation-based assessment of the P-glycoprotein expression-activity relationship shows a drug and system dependency
Simulation-based assessment of the P-glycoprotein expression-activity relationship shows a drug and system dependency
In vitro-in vivo extrapolation (IVIVE) of P-glycoprotein (P-gp) transporter activity bears two important assumptions: (1) ...
A physics-informed neural network approach for estimating population-level pharmacokinetic parameters from aggregated concentration data
A physics-informed neural network approach for estimating population-level pharmacokinetic parameters from aggregated concentration data
The pharmacokinetic literature is rich in aggregated concentration data that contain valuable information, yet tools to ex...
On the existence conditions of interaction indices in response surface models
On the existence conditions of interaction indices in response surface models
Response-surface models (RSMs) are widely used to characterize the combined effects of two agents and to classify their in...
Model informed assessment of QT prolongation during drug development: a five-year retrospective analysis of EMA scientific advices
Model informed assessment of QT prolongation during drug development: a five-year retrospective analysis of EMA scientific advices
Regulatory evaluation of QT interval prolongation remains central to cardiac safety assessment in drug development. Since ...
Uncertainty undermines the validity of antimicrobial pharmacodynamics
Uncertainty undermines the validity of antimicrobial pharmacodynamics
Antimicrobial therapy is informed by quantitative models of drug disposition and action. These models utilize experimental...
Assessing the impact of bacterial heterogeneity on bacteriophage population dynamics
Assessing the impact of bacterial heterogeneity on bacteriophage population dynamics
Bacteriophages follow complex replication dynamics in codependence with their host cells. The corresponding dynamics are u...
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...
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