Objectives: TYRP1-TCB is a CD3 T-cell bispecific (CD3-TCB) antibody developed for the treatment of advanced melanoma [1]. Upon dual binding…
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Optimizing Molecule Design for Bispecific Antibodies in Immuno-Oncology: A Case Study with FAP-4-1BBL
Objectives: FAP-4-1BBL is a T-cell bispecific antibody exerting 4-1BB costimulation only while simultaneously bound to the Fibroblast Activation Protein (FAP)…
Read moreDevelopment of a physiologically based pharmacokinetic model for intratumoral biodistribution of magnetic iron oxide nanoparticles
Introduction: Iron oxide nanoparticles (NPs), particularly magnetic iron oxide (MIO) nanoparticles, may provide a potential therapeutic intervention in therapy, due…
Read moreAutomatic Development of Pharmacokinetic Structural Models – Pharmpy Model Search Tool
Introduction: The current development strategy of population pharmacokinetic models is a complex and iterative process that is manually performed. Such…
Read moreMarginal No-U-Turn Sampler for Bayesian Analysis in Pharmacometrics
Objectives: The number of parameters in hierarchical models increases with the number of sub-groups. In pharmacometrics, each sub-group is a…
Read morePopulation-level treatment optimization using a multi-objective optimization strategy
Objectives: Optimizing the design of drug treatment schedules can be complex process as it may requires simultaneous consideration of multiple…
Read morePhysiologically based pharmacokinetic modeling and simulations to characterize the effect of cyclodextrins on the exposure of asciminib in lieu of clinical trials
Objectives: In a clinical study, co-administration of multiple doses of an itraconazole oral solution containing hydroxypropyl-beta-cyclodextrin (HP-beta-CD) at a total…
Read moreCombining physiologically based pharmacokinetic modeling and simulations and allometry to inform the starting dose of asciminib in pediatric patients
Introduction: Asciminib (Scemblix®), is a first-in-class BCR-ABL1 inhibitor that has been approved by the FDA for the treatment of adult patients…
Read moreModel-informed Precision Dosing for vancomycin in children between 28 days and 18 years: Does the use of a multi-model approach improve the predictive performance?
Objectives: Model-informed precision dosing (MIPD) using Bayesian forecasting is a useful tool for individualizing therapy in children and thus may…
Read moreUtilizing model informed drug development to support study design for Tovorafenib (DAY101), a novel, type II, pan RAF kinase inhibitor: a focus on longitudinal safety markers
Objectives: Growth, survival, and differentiation, are key cell functions regulated by pathways such as the mitogen-activated protein kinase (MAPK) signaling…
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