Introduction: Over last decade the Quantitative systems pharmacology (QSP) has matured to an approach recognized by regulatory agencies, which is…
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OpenPMX software for simulation and estimation in pharmacometrics
Introduction: Nonlinear mixed-effects models are fundamental to pharmacometrics, and the first-order conditional estimation with interaction (FOCE-I) method implemented in NONMEM[1]…
Read moreEfficient generation of virtual populations using machine learning in R
Introduction In recent years, several approaches to data synthesis have been proposed that can be used for generating virtual populations…
Read morePOPULATION PHARMACOKINETIC/PHARMACODYNAMIC MODELING AND SIMULATION ANALYSIS OF LESIGERCEPT, A LONG-ACTING IgETrap-Fc PROTEIN, TO SUPPORT DOSE SELECTION IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA
Objectives Lesigercept (YH35324) is a long-acting IgETrap-Fc fusion protein with a dual mechanism of action, binding circulating free immunoglobulin E…
Read moreImproved Numerical Stability with Phoenix NLME (QRPEM) in a Complex Sequential PK/PD Modeling Workflow
Overview: NONMEM has long been the industry standard for nonlinear mixed-effects (NLME) modeling, yet alternative platforms such as Phoenix NLME…
Read moreIdentifiability-aware variational autoencoder for inference of NONLINEAR mixed effect models based on ordinary differential equations
Objectives: We propose NN-NLME, a variational autoencoder framework for identifiability-aware parameter estimation with uncertainty quantification in nonlinear mixed-effects models governed…
Read moreEarly go/no-go decisions in clinical trials using a DeepNLME joint tumor growth dynamics and overall survival model
Introduction/Objectives: Overall survival (OS) endpoints in oncology clinical trials require prolonged follow-up, delaying critical go/no-go decisions. Early tumor growth dynamics…
Read morePHARMACOKINETIC–PHARMACODYNAMIC MODELING AND IN VIVO DRUG RELEASE EVALUATION OF CARVEDILOL CONTROLLED-RELEASE FORMULATIONS IN SPONTANEOUSLY HYPERTENSIVE RATS
Introduction/Objectives: Hypertension (HTN) remains the most important modifiable risk factor for cardiovascular disease and cardiovascular mortality worldwide.(1) Reductions in systolic…
Read morePharmacokinetic/Pharmacodynamic and Disease Progression Models to support Sefaxersen Phase 2 read out in Patients with Geographic Atrophy
Introduction: Geographic Atrophy (GA), a progressive and advanced form of age-related macular degeneration characterized by irreversible retinal damage, remains an…
Read morePOPULATION PHARMACOKINETICS OF MYCOPHENOLIC ACID IN PATIENTS WITH HIGH-GRADE LOCALLY ADVANCED OR METASTATIC OSTEOSARCOMA
Objective: Osteosarcoma is the most common primary bone malignancy in children and adolescents, and outcomes remain poor for patients with…
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