Introduction: Pharmaceutical modeling and simulation (Pumas) software is a pharmacometrics software program developed on Julia language platform (1). Modeling and…
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Model-Based Meta-Analysis in Newly Diagnosed and Relapsed Refractory Multiple Myeloma to Support Outcome-Efficacy Translations and Extrapolations Across Lines of Therapy
Introduction: Drug development for multiple myeloma (MM) is complex for multiple reasons: 1) long durations to demonstrate clinical benefit (overall…
Read moreLutathera dose determination and justification in adolescents via population PK and dosimetry modeling and simulation
Introduction: [177Lu]Lu-DOTA-TATE (Lutathera®) is an approved drug used for the treatment of somatostatin receptor-positive (SSTR-positive) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)…
Read moreSimulation study to evaluate the identifiability of a non-linear multi-level joint model for the follow-up of patients with cancer
Introduction: In oncology, the sum of longest diameters (SLD) is commonly used to follow the dynamics of patient tumor size…
Read morePharmacokinetic Simulation Study: Exploring Lamotrigine’s Impact Across Diverse Patient Populations
Introduction: The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved lamotrigine for treating various central nervous…
Read moreA revised population pharmacokinetic model for recombinant fusion protein linking recombinant coagulation factor IX with recombinant albumin
Introduction: In haemophilia, the vast majority of the existing population pharmacokinetic (PK) models use weight (WT) to normalize the PK…
Read moreBayesian forecasting of recombinant factor IX-Fc fusion protein concentrate dosing in haemophilia B patients: Comparison of the performance of two population pharmacokinetic models
Introduction: Recombinant factor IX Fc fusion protein (rFIX-Fc) is an extended half-life (EHL)-clotting factor concentrate administered to haemophilia B patients….
Read moreLactation related milk volume changes: implementation in a PBPK cow model for oxytetracycline
Objectives: Lactation is a complex physiological process that is influenced by various factors, including maternal physiology, lactation stage, and milk…
Read moreCharacterizing Bootstrap Model Selection Variability Through an Automated Model Building Approach
Introduction and Objectives:The development of a population pharmacokinetic (PK) model is a challenging and time-consuming procedure. There are several automatic…
Read moreSAAM II: Selected Software Use Cases in Modern PK-PD Data Analysis
Introduction: Simulation Analysis and Modeling II (SAAM II) is perhaps the most renowned software for compartmental modeling. Compartmental modeling is the…
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