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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...
Impact of covariate model building methods on their clinical relevance evaluation in population pharmacokinetic analyses: comparison of the full model, stepwise covariate model (SCM) and SCM+ approaches
Impact of covariate model building methods on their clinical relevance evaluation in population pharmacokinetic analyses: comparison of the full model, stepwise covariate model (SCM) and SCM+ approaches
Covariate analysis in population pharmacokinetics is key for adjusting doses for patients. The main objective of this work...
Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulations
Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulations
Cancer is one of the most common and fatal diseases worldwide and kills millions of people every year. Cancer drug resista...
Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration
Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration
DZIF-10c (BI 767551) is a recombinant human monoclonal antibody of the IgG1 kappa isotype. It acts as a SARS-CoV-2 neutral...
Translational population target binding model for the anti-FcRn fragment antibody efgartigimod
Translational population target binding model for the anti-FcRn fragment antibody efgartigimod
Efgartigimod is a human IgG1 antibody Fc-fragment that lowers IgG levels through blockade of the neonatal Fc receptor (FcR...
Model-informed approach to estimate treatment effect in placebo-controlled clinical trials using an artificial intelligence-based propensity weighting methodology to account for non-specific responses to treatment
Model-informed approach to estimate treatment effect in placebo-controlled clinical trials using an artificial intelligence-based propensity weighting methodology to account for non-specific responses to treatment
In randomized, placebo controlled clinical trials (RCT) in major depressive disorders (MDD), treatment response (TR) is es...
Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials
Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials
Composite scale data consists of numerous categorical questions/items that are often summed as a total score and are commo...
A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients
A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients
Current treatment recommendations mainly rely on rule-based protocols defined from evidence-based clinical guidelines, whi...
Semi-mechanistic modeling of resistance development to β-lactam and β-lactamase-inhibitor combinations
Semi-mechanistic modeling of resistance development to β-lactam and β-lactamase-inhibitor combinations
The use of β-lactam (BL) and β-lactamase inhibitor (BLI) combinations, such as piperacillin-tazobactam (PIP-TAZ)...
Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms
Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms
Physiologically based pharmacokinetic (PBPK) models can be used to leverage physiological and in vitro data to predict mon...
Population pharmacokinetics and pharmacodynamics of efmarodocokin alfa (IL-22Fc)
Population pharmacokinetics and pharmacodynamics of efmarodocokin alfa (IL-22Fc)
Efmarodocokin alfa (IL-22Fc) is a fusion protein of human IL-22 linked to the crystallizable fragment (Fc) of human IgG4. ...
Learning pharmacometric covariate model structures with symbolic regression networks
Learning pharmacometric covariate model structures with symbolic regression networks
Efficiently finding covariate model structures that minimize the need for random effects to describe pharmacological data ...
Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
There are many challenges with rare diseases drug development and rare oncology indications are not different. To understa...
Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model
Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model
In-vitro to in-vivo correlations (IVIVC), relating in-vitro parameters like IC50 to in-vivo drug exposure in plasma and tu...
Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach
Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach
Biological therapies may act as immunogenic triggers leading to the formation of anti-drug antibodies (ADAs). Population p...
Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs
Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs
Monoclonal antibodies (mAbs) are becoming an important therapeutic option in veterinary medicine, and understanding the ph...
Evaluation of prompt engineering strategies for pharmacokinetic data analysis with the ChatGPT large language model
Evaluation of prompt engineering strategies for pharmacokinetic data analysis with the ChatGPT large language model
To systematically assess the ChatGPT large language model on diverse tasks relevant to pharmacokinetic data analysis. Chat...
Low-dimensional neural ODEs and their application in pharmacokinetics
Low-dimensional neural ODEs and their application in pharmacokinetics
Machine Learning (ML) is a fast-evolving field, integrated in many of today’s scientific disciplines. With the recen...
Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy
Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy
Clinical studies have found there still exists a lack of gene therapy dose-toxicity and dose-efficacy data that causes gen...
Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs)
Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs)
A next generation multiscale quantitative systems pharmacology (QSP) model for antibody drug conjugates (ADCs) is presente...
Correction to: Training the next generation of pharmacometric modelers: a multisector perspective
Correction to: Training the next generation of pharmacometric modelers: a multisector perspective
Astellas, Northbrook, IL, USAPeter L. BonateAridhia Bioinformatics, Glasgow, Scotland, UKJeffrey S. BarrettMerck & Co....
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