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Predicting efficacy assessment of combined treatment of radiotherapy and nivolumab for NSCLC patients through virtual clinical trials using QSP modeling
Predicting efficacy assessment of combined treatment of radiotherapy and nivolumab for NSCLC patients through virtual clinical trials using QSP modeling
Non-Small Cell Lung Cancer (NSCLC) remains one of the main causes of cancer death worldwide. In the urge of finding an eff...
On inductive biases for the robust and interpretable prediction of drug concentrations using deep compartment models
On inductive biases for the robust and interpretable prediction of drug concentrations using deep compartment models
Conventional pharmacokinetic (PK) models contain several useful inductive biases guiding model convergence to more realist...
Note on importance of correct stoichiometric assumptions for modeling of monoclonal antibodies
Note on importance of correct stoichiometric assumptions for modeling of monoclonal antibodies
Pharmacokinetic modeling of monoclonal antibodies (mAbs) with non-linear binding is based on equations of the target-media...
Oral docetaxel plus encequidar – A pharmacokinetic model and evaluation against IV docetaxel
Oral docetaxel plus encequidar – A pharmacokinetic model and evaluation against IV docetaxel
The development of optimized dosing regimens plays a crucial role in oncology drug development. This study focused on the ...
Model-based comparison of subcutaneous versus sublingual apomorphine administration in the treatment of motor fluctuations in Parkinson’s disease
Model-based comparison of subcutaneous versus sublingual apomorphine administration in the treatment of motor fluctuations in Parkinson’s disease
The objective of this study was to compare the effectiveness of subcutaneous (SC) and sublingual (SL) formulations of apom...
General quasi-equilibrium multivalent binding model to study diverse and complex drug-receptor interactions of biologics
General quasi-equilibrium multivalent binding model to study diverse and complex drug-receptor interactions of biologics
Pharmacokinetics and pharmacodynamics of many biologics are influenced by their complex binding to biological receptors. B...
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...
A review of the physiological effects of microgravity and innovative formulation for space travelers
A review of the physiological effects of microgravity and innovative formulation for space travelers
During the space travel mission, astronauts’ physiological and psychological behavior will alter, and they will star...
Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data
Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data
The generation of synthetic patient data that reflect the statistical properties of real data plays a fundamental role in ...
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...
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 (&#...
Computing optimal drug dosing regarding efficacy and safety: the enhanced OptiDose method in NONMEM
Computing optimal drug dosing regarding efficacy and safety: the enhanced OptiDose method in NONMEM
Recently, an optimal dosing algorithm (OptiDose) was developed to compute the optimal drug doses for any pharmacometrics m...
Recommendations for a standardized publication protocol for a QSP model
Recommendations for a standardized publication protocol for a QSP model
Development of a Quantitative Systems Pharmacology (QSP) model is a long process with many iterative steps. Lack of standa...
A quantitative systems pharmacology model of plasma kallikrein-kinin system dysregulation in hereditary angioedema
A quantitative systems pharmacology model of plasma kallikrein-kinin system dysregulation in hereditary angioedema
Hereditary angioedema (HAE) due to C1-inhibitor deficiency is a rare, debilitating, genetic disorder characterized by recu...
Maximum a posteriori Bayesian methods out-perform non-compartmental analysis for busulfan precision dosing
Maximum a posteriori Bayesian methods out-perform non-compartmental analysis for busulfan precision dosing
Dose personalization improves patient outcomes for many drugs with a narrow therapeutic index and high inter-individuality...
Longitudinal modeling of efficacy response in patients with lupus nephritis receiving belimumab
Longitudinal modeling of efficacy response in patients with lupus nephritis receiving belimumab
Belimumab was approved for active lupus nephritis (LN) in adults in the European Union and patients ≥ 5 ...
Evaluation of ChatGPT and Gemini large language models for pharmacometrics with NONMEM
Evaluation of ChatGPT and Gemini large language models for pharmacometrics with NONMEM
To assess ChatGPT 4.0 (ChatGPT) and Gemini Ultra 1.0 (Gemini) large language models on NONMEM coding tasks relevant to pha...
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...
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...
How drug onset rate and duration of action affect drug forgiveness
How drug onset rate and duration of action affect drug forgiveness
Medication nonadherence is one of the largest problems in healthcare today, particularly for patients undergoing long-term...
Thoughts on plagiarism and the case against Claudine Gay
Thoughts on plagiarism and the case against Claudine Gay
Plagiarism has been all over the news since the end of 2023 when Claudine Gay, Presid...
A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations
A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations
Balovaptan is a brain-penetrating vasopressin receptor 1a antagonist previously investigated for the core symptoms of auti...
Population pharmacokinetics of the dual endothelin receptor antagonist aprocitentan in subjects with or without essential or resistant hypertension
Population pharmacokinetics of the dual endothelin receptor antagonist aprocitentan in subjects with or without essential or resistant hypertension
Aprocitentan is a novel, potent, dual endothelin receptor antagonist that recently demonstrated efficacy in the treatment ...
A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics
A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics
Protein therapeutics have revolutionized the treatment of a wide range of diseases. While they have distinct physicochemic...
Subgroup identification-based model selection to improve the predictive performance of individualized dosing
Subgroup identification-based model selection to improve the predictive performance of individualized dosing
Currently, model-informed precision dosing uses one population pharmacokinetic model that best fits the target population....
Fourteenth American Conference on Pharmacometrics (ACoP14) – Innovation and Diversity: Redefining Pharmacometrics
Fourteenth American Conference on Pharmacometrics (ACoP14) – Innovation and Diversity: Redefining Pharmacometrics
The author, serving as the Chair of ACoP14, expresses profound gratitude to the committed members of the ACoP14 Planning C...
Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis
Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis
Brepocitinib is an oral selective dual TYK2/JAK1 inhibitor and based on its cytokine inhibition profile is expected to pro...
An industry perspective on current QSP trends in drug development
An industry perspective on current QSP trends in drug development
2023 marks the 10th anniversary of Natpara’s submission to the US FDA, which led to the first recorded regulatory in...
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...
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