Thursday 7 May, 2026
Introduction: Early-phase dose-finding generally focuses on toxicity, but new approaches are shifting to a more comprehensive quantification of benefit-risks including…
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Global sensitivity analysis of a mechanistic PK/PD model for T cell engager–mediated peripheral B‑cell depletion
Thursday 7 May, 2026
Introduction: Auto-antibodies produced by B cells drive autoimmune diseases such as rheumatoid arthritis (1). B cell depletion aiming to restore…
Read moreTime matters: Predicting gemcitabine exposure in the pediatric brain with diffuse midline glioma using LeiCNS-PK3.0
Thursday 7 May, 2026
Objectives: Gemcitabine shows strong in vitro promise against H3K27M-altered diffuse midline gliomas (DMGs), a rare and aggressive pediatric brain cancer…
Read moreBenchmarking a Mechanistic Immunogenicity Framework: Aligning Sequence-Based Epitope Predictions with Clinical Observations
Thursday 7 May, 2026
Objective: Immunogenicity prediction is a critical component of monoclonal antibody (mAb) development. The emergence of anti-drug antibodies (ADA) remains a…
Read morePOPULATION PHARMACOKINETICS AND EXPOSURE-RESPONSE ANALYSES OF NAVEPEGRITIDE IN CHILDREN WITH ACHONDROPLASIA
Thursday 7 May, 2026
Introduction: Achondroplasia (ACH) is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant leading…
Read moreA Model-Informed Quantitative Framework for First-in-Human Dose Selection of T-Cell Receptor Mimetics in Acute Myeloid Leukemia
Thursday 7 May, 2026
Objectives: T-cell receptor mimetic (TCRm) T-cell engagers (TCEs) that recognize peptide-Human Leukocyte Antigen (pHLA) complexes represent an emerging class of…
Read moreDOSE SELECTION BY A MODEL-INFORMED DRUG DEVELOPMENT (MIDD) APPROACH FOR NAPORAFENIB AND TRAMETINIB COMBINATION IN PATIENTS WITH MELANOMA
Thursday 7 May, 2026
Introduction: Naporafenib is a potent and selective adenosine triphosphate (ATP)-competitive inhibitor of the wild-type CRAF and BRAF protein kinases and…
Read moreA population covariate modeling framework for IMPRES-M, the impulse-response modeling for population PK analysis based on P-splines
Thursday 7 May, 2026
Introduction/Objective: IMPRESM is a modeling tool for PK profile estimation and simulation, based on semi-parametric smoothing using P-splines and an…
Read moreA population modelling framework to support early clinical development of BI-1206, a monoclonal antibody blocking FcγRIIB
Thursday 7 May, 2026
Objectives BI-1206 is a fully human monoclonal antibody that targets the only inhibitory Fcγ receptor (FcγRIIB), a regulator of antibody…
Read moreLATE TREATMENT INITIATION LEADS TO REDUCED ANTIVIRAL POTENCY OF NIRMATRELVIR AND GS-441524 AGAINST IN VITRO SARS-COV-2 INFECTION
Thursday 7 May, 2026
Introduction: The timing of initiation is critical in antiviral treatment. Viral dynamic (VD) modeling is widely used to study the…
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