Introduction: Chemotherapy-induced damage of hematopoietic stem and progenitor cells (HSPCs) in bone marrow is a major cause of anemia and…
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A Whole-body Mechanistic Physiologically-based Pharmacokinetic Modeling of Intravenous Iron
Introduction: Iron is essential for every cell of the mammalian organism. Iron deficiency, with or without anemia, is frequent worldwide,…
Read moreEmpirical Population Pharmacodynamic Models for beti-cel for the Treatment of Patients with β-Thalassemia who Require Regular Transfusions.
Introduction: β-thalassemia is a rare hereditary genetic blood disease caused by mutations in the β-globin gene, resulting in reduced or…
Read moreEvaluation of the robustness of methods for model-based bioequivalence analysis for biosimilars: Clenoliximab as a case study
Objectives: Regulatory approval of biosimilars includes comparison of the pharmacokinetic (PK) profiles of the biosimilar and the innovator reference product…
Read moreShowcasing the potential of PBPK modeling to inform drug-drug interactions specific recommendations for pediatric labeling: omeprazol case example
Introduction: Exposure-matching approach is commonly agreed to bridge efficacy labeling information from adults to pediatrics when it is possible to…
Read moreEsophageal Eosinophil Count and the Endoscopic Reference Score Remodeling Subscore Do Not Correlate in Placebo Treated Eosinophilic Esophagitis Patients: Phase 2 Proof-of-Concept and Phase 3 TREET Studies
Objectives: Eosinophilic esophagitis (EoE) is a chronic, progressive type 2 inflammatory disease of the esophagus. Although eosinophils are the hallmark of…
Read moreQuality of Life and Symptom Burden Among Patients With Eosinophilic Esophagitis in a Real-World Setting
Objectives: Eosinophilic esophagitis (EoE) is a chronic type 2 inflammatory disease of the esophagus that substantially impairs quality of life…
Read morePopulation pharmacokinetics of cytarabine and its metabolite in patients with acute myeloid leukemia: effect of cytidine deaminase activity.
Objectives: Cytarabine-based chemotherapy represents a cornerstone in the current leukemia’s therapeutic arsenal, yet the outcomes remain unsatisfactory due to toxicity and…
Read moreModelling of plasma unbound Ceftriaxone: can we improve efficacy in clinical practice ?
Introduction: Ceftriaxone, a third generation semisynthetic cephalosporin with a long half-life, is a cornerstone antibiotic for critically ill patients with…
Read moreOpen-science solutions enabled within a digital research environment to support MIDD (Model Informed Drug Development) and precision dosing
Objectives: We propose to enhance the outreach and reliability of current open-science solutions supporting MIDD and precision dosing as part of…
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