Objective 1: Extend the linear model to nonlinear and delayed-effect models
Objectiv 2: Automation of data preparation, model selection, and reporting
mlxDesignEval: A Novel R Package for Design Evaluation Based on MonolixSuite
Develop an R package for design evaluation which can use Monolix or Simulx projects as input
Improvements in Data Quality Can Boost Efficiency and Reduce Development Costs: Findings from a Survey of Pharmacometric CROs
Modern drug development, which can take up to 15 years and cost as much as $11 billion USD, relies heavily on high-quality data.
Improvements in Data Quality Can Boost Efficiency and Reduce Development Costs: Findings from a Survey of Pharmacometric CROs
Modern drug development, which can take up to 15 years and cost as much as $11 billion USD, relies heavily on high-quality data1. Recognizing the criticality of attaining quality data that is easily convertible to analysis-ready datasets, a survey was developed to obtain baseline information on data quality and data standards, largely from a CRO perspective.
Prediction of Clinical Outcomes in a Heterogenous NSCLC Virtual Patient Population: a Quantitative Systems Pharmacology (QSP) Approach
Non-small cell lung cancer (NSCLC) is a major cause of mortality in the United States[1].
Quantitative Systems Toxicology (QST) Modeling Using BIOLOGXsym and Mechanistic Toxicity Data From a Biomimetic Liver Microphysiology System Predicts Biologics-induced Liver Injury
While biologics offer promise in addressing a range of unmet medical needs, clinically observed BILI events are concerning for drug developers, health care providers and patients.
Predicting Brinzolamide Ocular Response in Humans Using an Ocular PBPK-PD Modeling and Simulation
The development of generic ophthalmic drug products indicated for intraocular pressure (IOP) reduction typically relies on comparative pharmacodynamic (PD) endpoint bioequivalence (BE) studies.
Clustering of Environmental Compounds Based on Structure and Toxicokinetic Properties
Traditional toxicokinetic (TK) models rely heavily on in vivo data, necessitating animal testing. At the same time, the scientific toolbox is expanding with new approach methodologies (NAMs) that do not rely on TK studies.
Accurate Prediction of Liver Fat Reductions Across Range of Weight Loss by Quantitative Systems Pharmacology Modeling
Weight loss has positive effects on reducing hepatic lipid burden in MASH patients. Reports using various...
Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations Leads to Prediction of Liver Safety for Acute Otenaproxesul Dosing
Otenaproxesul (ATB-346), a drug that combines naproxen with a thiobenzamide antioxidant, is being developed as an NSAID that reduces gut toxicity effects. Liver...
Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus® to Predict Hepatic Concentrations
Infliximab (IFX), ipilimumab (IPI), and nivolumab (NIVO) have been associated with hepatotoxicity...
Simulated CD8+ T Cell-Mediated Liver Injury During Ipilimumab Administration in a Simulated Population (SimPops®) Demonstrates Profiles Consistent with Observed Clinical Data
Immune checkpoint inhibitors (ICIs) have revolutionized treatment of various cancers. They act by releasing the brakes on immune responses to permit immune-mediated tumor cell killing...
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The recent availability of effective GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients. Understanding the balance between body weight (BW) loss...
Comparison of Sensitivity Analysis Methods in the Context of a QSP Model for Gout
As quantitative systems pharmacology (QSP) models are increasingly used to inform key...
Eculizumab as a Key Comparator for the Evaluation of Complement Targeted Novel Therapeutic Strategies with a QSP Model
Paroxysmal nocturnal hemoglobinuria (PNH) is one of multiple diseases in which complement dysregulation, leading to...
Modeling progression and treatment of prostate cancer using the Thales QSP software platform
Metastatic, castration resistant prostate cancer (mCRPC) is an aggressive form of prostate cancer in...
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The availability of effective GLP-1 receptor agonists (GLP-1RAs) for obesity treatment has greatly benefited patients. Balancing body weight (BW) loss with nausea is crucial to predict the effectiveness of these medications, along with understanding the impact of delivery methods. Quantitative Systems Pharmacology (QSP) modeling helps predict efficacy and adverse events, assessing key differences and similarities between treatment protocols.
Weight Loss and Nausea from Obesity Treatments are Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided...
Mechanistic Representation of Clusterin, a Damage Biomarker for Early Detection of Drug-induced AKI
Novel biomarkers have the potential to address early diagnosis and...
Orforglipron Weight Loss and Nausea Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients