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Mon, Nov 11
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Tuesday, November 12, 2024
7:00 AM – 5:00 PM
MST
(T-001) A Model-based Pharmacokinetic Simulation Tool to Aid Dose Selection of Antisense Oligonucleotides Administered Intrathecally in Pediatrics
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7:00 AM – 5:00 PM
MST
(T-002) Representation of antibodies is key to generate a predictive vaccine quantitative systems pharmacology (QSP) model
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7:00 AM – 5:00 PM
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(T-005) A novel PBPK/PD model of preclinical data projects the human pharmacologically active dose of a Biologic that modulates immunosuppressive immune cells in the tumor microenvironment
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7:00 AM – 5:00 PM
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(T-006) Inhibitory Potential of Cannabidiol on Major CYP450s Enzymes: Insights from Physiological-based Pharmacokinetic Modeling
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7:00 AM – 5:00 PM
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(T-007) Population Pharmacokinetics of Enoxaparin in Neonates and Infants
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7:00 AM – 5:00 PM
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(T-008) Quantitative Systems Pharmacology (QSP) model for combined targeting of BAFF and CD40 pathways in systemic lupus erythematosus
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7:00 AM – 5:00 PM
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(T-009) Development of QSP platform model for predicting clinical efficacy and CRS incidence of CD3 bispecifics in STEAP1 Prostate Cancer
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7:00 AM – 5:00 PM
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(T-010) A quantitative systems pharmacology model framework for combined clinical efficacy and hematological toxicity predictions for antibody drug conjugates
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7:00 AM – 5:00 PM
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(T-011) A multi-stage modeling approach towards predicting cytokine release syndrome (CRS) in patients receiving Mosunetuzumab
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7:00 AM – 5:00 PM
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(T-012) popPK & ER analysis of amivantamab in combination with chemotherapy for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer after osimertinib failure
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7:00 AM – 5:00 PM
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(T-013) A hybrid semi-mechanistic and machine learning framework to predict Cytokine Release Syndrome following T-cell engaging immunotherapies
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7:00 AM – 5:00 PM
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(T-014) Longitudinal Population Pharmacokinetic/Pharmacodynamic Modeling of Continuous Efficacy Endpoint and Biomarker for a Novel Compound
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7:00 AM – 5:00 PM
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(T-015) A quantitative systems pharmacology model to explore resistance mechanisms and combination strategies in ALK+ NSCLC targeted therapies
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7:00 AM – 5:00 PM
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(T-016) Bridging the Gap: A Comprehensive Checklist for Hybrid Pharmacometrics-Machine Learning Model Building to Support Oncology Clinical Development
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7:00 AM – 5:00 PM
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(T-017) Application of an advanced gut PBPK model to characterize intestinal transport and P-glycoprotein-mediated drug-drug interaction: a case study with Digoxin and Clarithromycin
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7:00 AM – 5:00 PM
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(T-018) A Neuro-Dynamic Quantitative Systems Pharmacology (QSP) Model to Describe Pathophysiology of Alzheimer’s Disease and Inform Drug Development
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7:00 AM – 5:00 PM
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(T-019) Simulate modified Nonmem models using NMsim
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7:00 AM – 5:00 PM
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(T-020) Zolpidemsim: A Web-Application for Simulating Pharmacokinetics of Zolpidem
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7:00 AM – 5:00 PM
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(T-021) Semi-physiological population pharmacokinetic (PPK) model using dose optimization data for ASTX030, an oral fixed-dose combination (FDC) of CDA inhibitor cedazuridine and azacitidine in MDS patients
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7:00 AM – 5:00 PM
MST
(T-022) Comparing the Efficacy of Various Insulin Types: A Pharmacokinetic and Pharmacodynamic Modeling Study in Healthy Volunteers
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7:00 AM – 5:00 PM
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(T-023) Cost-effectiveness of paliperidone palmitate long-acting injectables for the treatment of schizophrenic patients: a joint pharmacometric/pharmacoeconomic approach
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7:00 AM – 5:00 PM
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(T-024) A Bayesian Approach to Item Response Theory Modeling for Exposure-Response Relationships in Stan
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7:00 AM – 5:00 PM
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(T-025) Meta-Analysis of Levamisole Pharmacokinetics Across Diverse Species
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7:00 AM – 5:00 PM
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(T-026) A Semi-Mechanistic Population Pharmacokinetic (PopPK) Model of Linvoseltamab With Considerations of Disease-Related Factors in Patients (Pts) with Relapsed/refractory (RR) Multiple Myeloma (MM)
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7:00 AM – 5:00 PM
MST
(T-027) Integrated Microphysiological System and PBPK Modeling for Prediction of Human Diclofenac Pharmacokinetics
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7:00 AM – 5:00 PM
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(T-028) Pooled population PK of alpelisib in patients with PIK3CA-related overgrowth spectrum and breast cancer
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7:00 AM – 5:00 PM
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(T-029) An R-based workflow for clinical trial simulation tool with application in type 1 diabetes studies
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7:00 AM – 5:00 PM
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(T-030) Integration of Temporal Single-Cell RNA Sequencing Data into Quantitative Systems Pharmacology Model of T Cell Differentiation
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7:00 AM – 5:00 PM
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(T-031) Comparison of Sensitivity Analysis Methods in the Context of a QSP Model for Gout
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7:00 AM – 5:00 PM
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(T-032) NMsim: Simulate Nonmem models seamlessly in R without any model reimplementation
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7:00 AM – 5:00 PM
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(T-033) A translational one pore and two pore whole body physiologically based pharmacokinetic model for ASOs, and siRNA-based therapeutics
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7:00 AM – 5:00 PM
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(T-034) Translational modeling identifies synergistic combinations of anti-microRNA-155 with standard-of-care drugs in non-small-cell lung cancer
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7:00 AM – 5:00 PM
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(T-035) Identifying Determinants of Vaccine Efficacy: A Mechanistic Modeling Approach
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7:00 AM – 5:00 PM
MST
(T-036) A Novel Empirical Drug Induced Autoinduction Model to Characterize the Population Pharmacokinetics of Repotrectinib with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
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7:00 AM – 5:00 PM
MST
(T-037) Exposure-Response Efficacy and Safety Analysis of Repotrectinib to Support the Dose Recommendation for Patients with ROS1-positive NSCLC
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7:00 AM – 5:00 PM
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(T-038) The PK-PD model of dexamethasone for fetal lung maturation and developmental neurotoxicity: A dose optimization study
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7:00 AM – 5:00 PM
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(T-039) Symbolic PBPK-PDE Modeling Using Open-Source Julia Tools
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7:00 AM – 5:00 PM
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(T-040) How to Make a Salad? Rethinking Pharmacometric/QSP Model Composition Using Open-Source Julia Tools
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7:00 AM – 5:00 PM
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(T-041) Bimekizumab population pharmacokinetic and exposure-response analyses in adults with moderate to severe hidradenitis suppurativa
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7:00 AM – 5:00 PM
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(T-042) Use of Model-informed Drug Development and Natural History Data to Inform the Development of Iluzanebart in ALSP: A Neurological Rare Disease
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7:00 AM – 5:00 PM
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(T-043) Advancing Drug Development through Enhanced Exposure-Response Analysis: The R-Shiny App ERpmx
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7:00 AM – 5:00 PM
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(T-044) A translational quantitative systems pharmacology modeling framework for FcRn antagonist therapy for myasthenia gravis
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7:00 AM – 5:00 PM
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(T-045) Mixed effect state space model application for data driven pharmacometrics modeling
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7:00 AM – 5:00 PM
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(T-046) A Mixed-effect Pharmacokinetic Model of R835, a Novel Dual IRAK1/4, in Healthy Volunteers After Administration of the Prodrug R289
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7:00 AM – 5:00 PM
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(T-047) FIVEDB as a tool for analysis of in vitro experimental data: cytokine production by primary cells and cell lines
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7:00 AM – 5:00 PM
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(T-048) App-based in vitro pharmacokinetic driver identification and in silico clinical trial assessment of pharmacokinetic driver models
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7:00 AM – 5:00 PM
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(T-049) Building Automated Pharmacometrics Analysis Workflows in R with NMsim
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7:00 AM – 5:00 PM
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(T-050) A review of OSP suite PBBM capabilities: looking ahead
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7:00 AM – 5:00 PM
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(T-051) Mechanistic model-based analysis of Total IgG kinetics and pathogenic autoantibody pharmacodynamics in autoimmune diseases
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7:00 AM – 5:00 PM
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(T-052) Modeling the Time-Varying Impact of Anti-Drug Antibody Formation on the Pharmacokinetics of a Human Monoclonal Antibody in a Preclinical Study
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7:00 AM – 5:00 PM
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(T-053) Modeling and inter-species scaling of plasma DHO as a biomarker to inform first-in-human dose selection for a novel DHODH inhibitor
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7:00 AM – 5:00 PM
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(T-054) The effect of CYP2B6 genotype on the clearance and autoinduction of efavirenz in healthy subjects and the subsequent impact on efavirenz exposure.
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7:00 AM – 5:00 PM
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(T-055) Population PK model on preclinical data for optimization of further clinical trial designs in oncology
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7:00 AM – 5:00 PM
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(T-056) A modified Bayesian information criterion (mBIC) with multiple testing correction for population pharmacokinetic model building
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7:00 AM – 5:00 PM
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(T-057) Hybrid Population PK-Machine Learning Model Approach to Predict Infliximab Concentrations in Pediatric Patients with Crohn's Disease
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7:00 AM – 5:00 PM
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(T-058) Exposure-response (E-R) relationship between PD-L1 recombinant monoclonal antibody IMC-001 in relapsed or refractory extranodal NK/T cell lymphoma nasal type patients
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7:00 AM – 5:00 PM
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(T-059) Population Pharmacokinetic Approach to Evaluate Current Recommended Dose of Tacrolimus on Korean Pediatric Liver Transplant Patients
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7:00 AM – 5:00 PM
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(T-060) AI-Driven Innovative Platform in Quantitative Pharmacology: Literature Insights and Automated Model Construction
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7:00 AM – 5:00 PM
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(T-061) Impact of PD-L2 on Relative Efficacy of Anti-PD-1 and Anti-PD-L1 Antibodies: Insights From QSP-Based Meta-Analysis
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7:00 AM – 5:00 PM
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(T-062) A Pharmacologically-informed Neural Ordinary Differential Equation Framework to Predict Preclinical Pharmacokinetics
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7:00 AM – 5:00 PM
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(T-063) Advancing Modeling of Hematologic Safety using a Semi-mechanistic Multivariate PK/PD Approach: Application to the ATR Inhibitor Tuvusertib in Early Phase Oncology Development
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7:00 AM – 5:00 PM
MST
(T-064) Pharmacokinetic-pharmacodynamic analysis of myelosuppression with raludotatug deruxtecan (R-DXd) in patients with advanced solid tumors
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7:00 AM – 5:00 PM
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(T-065) Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
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7:00 AM – 5:00 PM
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(T-066) A Novel Concentration-Based Time-Imputation Algorithm for Large Cohort Studies Missing Time-After-Dose Data for Stored Samples
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7:00 AM – 5:00 PM
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(T-067) A quantitative systems pharmacology-physiologically based pharmacokinetic model-guided antibiotics regimen design for the treatment of sepsis and septic shock patients
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7:00 AM – 5:00 PM
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(T-068) An integrated model of catabolic clearance mechanisms driving exposure-response confounding for immunotherapies in cancer: interactions between mAb drugs, Fc receptors, and endogenous serum proteins
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7:00 AM – 5:00 PM
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(T-069) Assessment of Disease Similarity among Different Racial and/or Ethnic Groups in Oncology: ABC Framework
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7:00 AM – 5:00 PM
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(T-070) A novel model for Platelets Dynamics: a pragmatic systems approach to characterize thrombocytopenia across multiple compounds and drug classes
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7:00 AM – 5:00 PM
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(T-071) A Framework for Evaluating Predictive Models Using Synthetic Image Covariates and Longitudinal Data
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7:00 AM – 5:00 PM
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(T-072) Exposure–Response Relationship of Dostarlimab With Chemotherapy in Primary Advanced/Recurrent Endometrial Cancer: Results From Interim Analysis Two of Part 1 of ENGOT-EN6-NSGO/GOG-3031/RUBY Trial
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7:00 AM – 5:00 PM
MST
(T-073) Bispecific T-cell engagers and cytokine release syndrome: Modeling molecule, indication and patient-specific aspects
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7:00 AM – 5:00 PM
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(T-074) Risk Assessment for Drug-Induced Hyperbilirubinemia: A Mechanistic Approach
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7:00 AM – 5:00 PM
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(T-075) Enhancing Parameter Estimation Process for Pharmacokinetic-Pharmacodynamic Models with Meta-heuristic Optimization Approaches
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7:00 AM – 5:00 PM
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(T-076) Population Pharmacokinetic-Pharmacodynamic Modeling for Triapine to Optimize Dosing Regimen
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7:00 AM – 5:00 PM
MST
(T-077) Quantitative Systems Pharmacology Modeling of Loncastuximab Tesirine Combined with Mosunetuzumab and Glofitamab Helps Guide Dosing for Patients with DLBCL
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7:00 AM – 5:00 PM
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(T-078) A Bayesian Semi-Mechanistic Dose-Finding Design for Phase I Drug Combination Trials in Oncology
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7:00 AM – 5:00 PM
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(T-079) A mechanistic QSP model of CRS allows for quantitative assessment of dose priming of CD3 bispecific antibody (BsAb) therapeutics.
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7:00 AM – 5:00 PM
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(T-080) A phase I open-label sequential clinical trial and population oral minimal model to study pharmacodynamic interactions of dorzagliatin and empagliflozin in patients with type 2 diabetes and obesity
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7:00 AM – 5:00 PM
MST
(T-081) Application of Model Informed Drug Development (MIDD) to BT8009, a Bicycle Toxin Conjugate (BTC®), in Patients with Advanced Urothelial Cancer
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7:00 AM – 5:00 PM
MST
(T-082) Optimizing Clinical Dosing Strategies to Mitigate Corneal Toxicity: Ocular PBPK Model-Based Evaluation of the Extent and Rate of Therapeutic Protein Distribution in the Human Cornea
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7:00 AM – 5:00 PM
MST
(T-083) Application of quantitative systems pharmacology modeling in reverse translation
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7:00 AM – 5:00 PM
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(T-084) A COMBINED EX VIVO AND PHYSIOLOGICALLY-BASED PHARMACOKINETIC APPROACH TO INCORPORATE DRUG-DRUG INTERACTIONS FOR DOSING DURING CONTINUOUS RENAL REPLACEMENT THERAPY
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7:00 AM – 5:00 PM
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(T-085) Modeling progression and treatment of mCRPC using the Thales QSP software platform
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7:00 AM – 5:00 PM
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(T-086) Development of a Whole-Body Physiologically Based Pharmacokinetics (PBPK) Model for Predicting Dynamics of mRNA and Protein for LNP-Encapsulated mRNA Therapeutics
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7:00 AM – 5:00 PM
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(T-087) Population pharmacokinetics of cefepime in critically ill children and young adults
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7:00 AM – 5:00 PM
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(T-088) A Computational Modeling Framework to Provide a Feasibility Assessment, Inform Competitor Differentiation Strategy, Best-in-Class Properties, and Target Selection for Biologics Targeting IBD
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7:00 AM – 5:00 PM
MST
(T-089) Integrated Population Pharmacokinetic Model of Bemnifosbuvir and Metabolites
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7:00 AM – 5:00 PM
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(T-090) Whole-body Two-pore PBPK Model to Investigate the Disposition of Immunoglobulin M (IgM) in Mice
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7:00 AM – 5:00 PM
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(T-091) Fast Stepwise Selection Methods for Efficient Covariate Model Development in Population Data Analysis
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7:00 AM – 5:00 PM
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(T-092) Delineate: a Literature Co-Pilot for Quantitative Systems Pharmacology
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7:00 AM – 5:00 PM
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(T-093) Preclinical tumor growth inhibition modeling and simulation to support dosing regimen selection of a novel EWS-FLI1 inhibitor for Ewing sarcoma treatment
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7:00 AM – 5:00 PM
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(T-094) Cellular and Humoral Semi-mechanistic Immune Response Models of a Vaccine Candidate for Respiratory Syncytial Virus Infection
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7:00 AM – 5:00 PM
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(T-095) Modeling the Role of Organ Crosstalk and Cellular Adaptation in Multiple Organ Dysfunction Syndrome
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7:00 AM – 5:00 PM
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(T-096) Integrating Motor Function Scores of Spinal Muscular Atrophy in a Quantitative Systems Pharmacology Model of Neurofilament
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7:00 AM – 5:00 PM
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(T-097) Model Predictive Control Regulates Blood Pressure During Simulated Kidney Replacement Therapy
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7:00 AM – 5:00 PM
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(T-098) Population pharmacokinetic modeling of Binimetinib in Healthy Volunteers and Participants with BRAF V600-mutant or NRAS-mutant Solid Tumors
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7:00 AM – 5:00 PM
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(T-099) Acoramidis (ALXN2060) Population Pharmacokinetic Modeling and the Importance of Exploring Categorization of Covariate Values
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7:00 AM – 5:00 PM
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(T-100) Beyond Subcutaneous Dosing: Efficiency of liver-targeting siRNAs dosed via alternates routes and formulations.
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7:00 AM – 5:00 PM
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(T-101) A QSP model of atopic dermatitis to accelerate the clinical translation of novel combination therapies
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7:00 AM – 5:00 PM
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(T-102) Redefining Multidrug Resistance Quantitatively using Live Cell Functional Data
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7:00 AM – 5:00 PM
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(T-103) A model-based simulation workflow enables automated and accurate generation of clinical pharmacology summary statistics, a workflow and case-study.
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7:00 AM – 5:00 PM
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(T-104) Adaptation of the Glucose, Glucagon, Gastric-Inhibitory Peptide, Glucagon-like Peptide-1, and Insulin (4GI) Model for Simulation of Acute Meal Challenges with Infused Antagonists
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7:00 AM – 5:00 PM
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(T-105) Generating data-driven insights from the Alzheimer’s Disease Neuroimaging Initiative (ADNI): Towards establishing a QSP model of Alzheimer’s disease
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7:00 AM – 5:00 PM
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(T-106) Simulated CD8+ T Cell-Mediated Liver Injury During Ipilimumab Administration in a Simulated Population (SimPops®) Demonstrates Profiles Consistent with Observed Clinical Data
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7:00 AM – 5:00 PM
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(T-107) Comprehensive Human Quantitative Systems Pharmacology Models for Immuno-Oncology: Enhancing Decision-Making on Target Indications and Combination Strategies for New Drug Development
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7:00 AM – 5:00 PM
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(T-108) Comparison of NONMEM and AI-Based Approaches for Population Pharmacokinetic Simulations to Support Model-Informed Drug Development
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7:00 AM – 5:00 PM
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(T-109) Model-Based Analysis of Pharmacokinetics of Venglustat, a small-molecule inhibitor of glucosylceramide synthase, Using Pooled Data from Healthy Subjects and Patients with Lysosomal Storage Disorders
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7:00 AM – 5:00 PM
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(T-110) Simulation of Trial Predictions with Model Uncertainty using NMsim
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7:00 AM – 5:00 PM
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(T-112) Application of Machine Learning Methods to Predict Risk of Adverse Events in Clinical Trials
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7:00 AM – 5:00 PM
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(T-113) QSP model trained on preclinical data informs clinical dose selection for a T-cell engaging bispecific antibody for solid tumor indications
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7:00 AM – 5:00 PM
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(T-114) SAS Macro for Validation of NONMEM Data Items Pertaining to Implicit Expansion of Dose Records in Oral Dose Population Pharmacokinetic Datasets
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7:00 AM – 5:00 PM
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(T-115) Approaches for Developing a Robust Virtual Twin Workflow in Quantitative Systems Pharmacology Models
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7:00 AM – 5:00 PM
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(T-116) A DeepNLME-based Tumor Growth Dynamics and Overall Survival Model for Non Small Cell Lung Cancer
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7:00 AM – 5:00 PM
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(T-117) A High-Dose Methotrexate Dashboard: Integrating MTXPK.org into the Electronic Health Record to Facilitate Model-Informed Care for Pediatric Patients with Malignant Conditions
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7:00 AM – 5:00 PM
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(T-118) Population Pharmacokinetic and Exposure-Response Analyses of Neoadjuvant Nivolumab plus Chemotherapy, followed by Adjuvant Treatment with Nivolumab in Subjects with Resectable Stage II-IIIB NSCLC
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7:00 AM – 5:00 PM
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(T-119) Development of a Population Pharmacokinetic Model for Ganciclovir to Assess the Renal Impairment Impact in Chinese Patients
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7:00 AM – 5:00 PM
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(T-120) Assessing Sirolimus and Antiretroviral Interactions in People with HIV on Chronic ART: A Population Pharmacokinetic Approach in Non-Transplant Recipients
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7:00 AM – 5:00 PM
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(T-121) Joint bi-directional PK-ADA population modelling in immuno-oncology
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7:00 AM – 5:00 PM
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(T-122) A Quantitative Systems Pharmacology Approach to Understand the Variability of Patient Response to T-cell Bi-specifics in Hematological Malignancies
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7:00 AM – 5:00 PM
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(T-123) Monte-Carlo simulations to assess the probability of target attainment for cefepime and enmetazobactam in patients with complicated urinary tract infections
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7:00 AM – 5:00 PM
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(T-124) Translational modelling from preclinical data to predict human PK of monoclonal antibodies with engineered FcRn binding
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7:00 AM – 5:00 PM
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(T-125) Beyond the Michaelis-Menten: Evaluation of Novel IVIVE Approach for Predicting In Vivo Intrinsic Clearance from Hepatocyte Assays
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7:00 AM – 5:00 PM
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(T-126) Quantification of uncertainty in human dose predictions
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7:00 AM – 5:00 PM
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(T-127) Surface plasmon resonance enabled mechanistic pharmacokinetic/pharmacodynamic modeling to support covalent inhibitor drug development: Bruton’s tyrosine kinase inhibitor case study
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7:00 AM – 5:00 PM
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(T-128) Application of PKPD Principles to Drive the Discovery and Development of Novel BCR-ABL Tyrosine Kinase Inhibitors
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7:00 AM – 5:00 PM
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(T-129) A prototype mechanistic systems pharmacology model of Type 2 interventions in eosinophilic esophagitis
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7:00 AM – 5:00 PM
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(T-130) Development of the second-generation PBPK model to quantify OATP1B, P-gp, BCRP transporter and CYP3A4 enzyme activity changes for Chinese ESRD patients
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7:00 AM – 5:00 PM
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(T-131) A Bayesian Model-based CTS Tool to Optimize Clinical Trial Design in Duchenne Muscular Dystrophy
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7:00 AM – 5:00 PM
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(T-132) Impacts of dose titration on logistic exposure-response in simulated flexible-dose clinical trials
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7:00 AM – 5:00 PM
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(T-133) Placebo Response Model for Alopecia Areata: A Model-based Meta-analysis of Randomized Controlled Trials
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7:00 AM – 5:00 PM
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(T-134) Integrating Physiologically Based Pharmacokinetic (PBPK) Modeling and Strain-Specific Exposure-Efficacy Requirements to Refine the Dosage Regimens for Voriconazole in a Pediatric Cancer Population
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7:00 AM – 5:00 PM
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(T-135) Potential Bias Evaluation of Conventional Exposure-Response Analysis Methods: A Small Molecule Cancer Drug Example
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7:00 AM – 5:00 PM
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(T-136) Unique Effect of the High-Fat Meal on the Pharmacokinetics of Omaveloxolone Explained by Physiologically Based Biopharmaceutics Modeling
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7:00 AM – 5:00 PM
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(T-137) Mechanistic physiologically-based pharmacokinetic platform model to characterize risk of cytochrome P450 based drug-drug interactions for bispecific T cell engagers in oncology patients
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7:00 AM – 5:00 PM
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(T-138) Modeling Patient Risk Factors and their Role in Dose Optimization for Oncological Trials
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7:00 AM – 5:00 PM
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(T-139) Population Pharmacokinetics and Exposure-response Analyses of Amivantamab Administered in Combination with Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Non-Small Cell Lung Cancer
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7:00 AM – 5:00 PM
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(T-140) Modeling the frequency of toxicity-induced dose modifications and their impact on conventional exposure-response analysis in targeted therapy
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7:00 AM – 5:00 PM
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(T-141) Model-Based Exploration of the Impact of Prophylactic Tocilizumab on IL-6 Dynamics in Multiple Myeloma Patients Receiving Teclistamab Treatment
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7:00 AM – 5:00 PM
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(T-142) PK-PD modeling of doxycycline, azithromycin, and their combination in treating severe scrub typhus using a general pharmacodynamic interaction (GPDI) model.
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