General Pharmacometrics

(M-001) Prediction of Percent Free Nerve Growth Factor Suppression following Administration of MEDI7352, a Bispecific Fusion Protein for Dual Targeting of NGF and TNFα, in Patients with Painful Diabetic Neuropathy and Osteoarthritis

(M-002) Population Pharmacokinetic Modeling of MEDI7352, a Bispecific Fusion Protein for Dual Targeting of NGF and TNFα, in Patients with Painful Diabetic Neuropathy and Painful Osteoarthritis of the Knee

(M-003) Characterizing the pharmacokinetics of MAM01, an extended half-life monoclonal antibody for the prevention of malaria using a population approach

(M-005) Transforming Pharmacometric Processes to deliver medicines to patients: Balancing Speed, Quality, and Innovation

(M-007) Intravenous Immunoglobulin G (IVIG)-Monoclonal Antibody (mAb) Drug Interactions: Time for Model-Informed Clinical Guidance?

(M-008) Exposure-Response Analysis of Efficacy and Safety for Nivolumab + Relatlimab Fixed-dose Combination (FDC) to Support Dose Justification in Patients with Unresectable or Metastatic Melanoma

(M-009) Translation of a Preclinical Tumor Growth Inhibition Model to a Clinical Setting: Two Approaches to Incorporate Resistance in a Tumor Dynamics Model

(M-010) Population Pharmacokinetic Modeling of Encorafenib and LHY746 In Participants with Solid Tumors in Phase 2 Studies: A Sequential Parent-Metabolite Model

(M-012) Population pharmacokinetics and pharmacodynamics analysis of PF-07328948, a branched-chain ketoacid dehydrogenase kinase inhibitor, in healthy participants

(M-016) Application of in silico Healthy Control Cohorts in the Analysis of Osivelotor Exposure in Organ Impairment

(M-024) A Population PK-PD Model-Informed Approach to Guide Formulation Development

(M-029) Bayesian Analysis of Nonclinical Studies to Inform Regimen Selection for Tuberculosis

(M-030) Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled Study

(M-031) Exposure-Response Analysis of Seladelpar in Patients With Primary Biliary Cholangitis

(M-032) Optimizing Pediatric Doses for Weight-Based Dosing Regimens Under Constraints

(M-033) Population Pharmacokinetic Analysis of Possible Drug-Drug Interactions between Mouse Double Minute 2 (MDM2) Inhibitor Navtemadlin and the Bruton's Tyrosine Kinase (BTK) Inhibitor Acalabrutinib in Patients with R/R CLL or R/R DLBCL

(M-047) Prediction of human pharmacokinetic profiles of Glyph(TM) platform prodrugs using animal and human data via a semi-mechanistic pharmacokinetic model

(M-050) Real-world Performance Assessment and Model Re-evaluation in Children and Adults

(M-051) Machine Learning Augmented Tumor Growth and Survival Models: Insights from Hepatocellular Carcinoma Data

(M-052) Exposure-Response Analysis of Guselkumab in Participants with Moderate to Severe Crohn’s Disease

(M-053) Exploratory population pharmacokinetic analysis of vixarelimab using a two-target quasi-steady-state TMDD model in healthy volunteers and patients with pruritic conditions

(M-054) Population pharmacokinetics and exposure-safety analysis of SGN-STNV (PF-08046055) in patients with locally advanced and/or metastatic solid tumors: Phase-1a/b study

(M-055) Real World Data Based Evaluation of a Novel TMDD Approximation Model

(M-056) Time-to-event exposure-response based clinical utility index framework to facilitate optimal dose selection

(M-069) Population Pharmacokinetic Analysis of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease

(M-070) Population pharmacokinetic and exposure-response analysis of high-dose methotrexate-associated mucositis in infant patients with acute lymphoblastic leukemia

(M-071) Dose optimization framework to estimate benefit-risk for oncology compounds: an integrated population model framework incorporating PK, safety, efficacy and impact of dose modifications

(M-072) Population Pharmacokinetics and Pharmacodynamic Analysis of MT-4561, a Novel Bromodomain-containing Protein 4 (BRD4) Protein Degrader

(M-073) Exposure-Response Analyses for Monthly Buprenorphine Extended-Release (BUP-XR) in Patients with Opioid Use Disorder and Frequent Fentanyl Use

(M-083) Disease progression simulation via generative AI: assessing the credibility of a conditional longitudinal autoencoder via a case study in Alzheimer’s Disease

(M-086) Model-Based Evaluation of Lumasiran Plasma and Liver Pharmacokinetics in Non-Human Primates

(M-087) An Integrated PK-PD Model to Characterize Circadian-Driven ACTH-Cortisol Interactions in Patients with Congenital Adrenal Hyperplasia

(M-088) PK/PD Analysis of the Primary Endpoint for Nipocalimab in Sjögren's Disease

(M-091) Auto-Induction and PD-Enhanced TMDD population PK Models for Engineered IL-15 cytokine Efbalropendekin alfa (XmAb24306) in Cancer Therapy

(M-094) Population Pharmacokinetic Analysis of Zimberelimab in Patients with Solid Tumors

(M-095) Population Pharmacokinetics and Exposure-response Analysis of Cemsidomide in Patients with Relapsed/Refractory Multiple Myeloma and Non-Hodgkin’s Lymphoma

(M-096) Simultaneous PASI Exposure Response Analysis of Ustekinumab in Subjects with Psoriasis and Psoriatic Arthritis

(M-097) Accounting for Temporal Differences in Fetal Exposure during Pregnancy using Masking

(M-101) A minimal model to support a CAR T-cell therapy development platform

(M-102) Strategic application of PK modeling in 505(b)(2) development for a new pediatric formulation

(M-103) Population Pharmacokinetic Analysis of QRL-201 in Plasma and CSF in Patients With Amyotrophic Lateral Sclerosis From A First-in-Human Phase 1 Multiple Ascending Dose Escalation Study

(M-104) Comparison of $PRED and $DES in NONMEM for time-varying categorical covariates in disease progression modeling.

(M-105) Designing Optimal Pharmacokinetic Sampling Strategies for Ketamine in Established Status Epilepticus: A Model-Based Simulation Study to Support the Ketamine Add-On Therapy for Established Status Epilepticus Treatment Trial

(M-106) An Integrated model of Lu-PSMA-617 dose, tumor dosimetry, PSA and OS to enable future study design

(M-107) Feasibility of predicting regional lung exposure from systemic pharmacokinetic data of generic orally inhaled drug products (OIDPs) via population pharmacokinetic and non-compartmental approaches

(M-108) Using Modeling and Simulation to Assess the Impact of the Pharmacokinetics and Biodistribution on the Absorbed and Biologically Effective Dose for Radioligand Therapies

(M-110) Re-evaluation of Fixed dosing versus Body Size-Based Dosing Approaches for Large Molecule Therapeutics in Adults

(M-111) Exposure-Response Relationship Between Litifilimab and Clinical Outcomes in Systemic Lupus Erythematosus Populations

(M-112) Development and Evaluation of PKPD Models for QT Interval Changes Post-Moxifloxacin Dosing in Non-Human Primates

(M-113) Characterization of PK Characteristics of IMMUNORHO after Intramuscular Administration for the Prevention of RhD Isoimmunisation in Rh(D) Negative Women Pregnant with Rh(D) Positive Fetuses: Population Pharmacokinetic Approach

(M-114) A Dose That Fits All: Model-Based Insights into the Impact of Obesity on Midazolam Oromucosal Pharmacokinetics in Adults

(M-115) Dosage modifications in exposure-response analyses of oncology drug development: the brigimadlin case study

(S-003) Population PK Modeling of Ziftomenib and its Metabolites in Healthy Subjects and in Patients with Relapsed or Refractory Acute Myeloid Leukemia

(S-004) Exposure-Response Analysis of Ziftomenib in Patients with Relapsed or Refractory Acute Myeloid Leukemia

(S-005) Amivantamab population pharmacokinetics analyses of PALOMA studies supporting the bridging from intravenous formulation to subcutaneous formulation in epidermal growth factor receptor-mutated non-small cell lung cancer

(S-008) Population PK-RO-IgG Modeling of Nipocalimab in Patients with Sjögren's Disease

(S-009) A novel approach for predicting the efficacy of updated vaccines when the correlate of protection is known

(S-010) Bayesian modeling allows early inference of pharmacokinetic/pharmacodynamic relationship for a novel small molecule STING agonist in Phase I

(S-011) Using translational in vitro-in vivo modeling to improve inhaled drug repurposing outcomes for COVID-19

(S-020) Population Pharmacokinetic Analysis of Domvanalimab in Patients with Solid Tumors

(S-024) Population Pharmacokinetics of AMG 193 and its Impact on SDMA Inhibition in Patients with Advanced MTAP-deleted Solid Tumors

(S-033) The Dose and Dosing Schedule Selection for an Investigational Immuno-Oncology Drug Based on a Pharmacokinetics and Pharmacodynamic Model of Tolerance

(S-034) Pharmacometric analysis of pharmacokinetics, safety, and efficacy data of migoprotafib in combination with divarasib for KRAS G12C-positive non-small cell lung cancer.

(S-040) Time-to-event analysis of iron homeostasis to inform survival in cancer patients

(S-045) Model-informed scheduling of drug combinations for optimal treatment of cancer: a case study of JDQ443 and TNO155 dose regimen optimization

(S-046) Assessment of Weight Loss by Amylin Receptor Agonists Alone and In Combination with GLP-1 Receptor Agonists: A Model-Based Meta-Analysis

(S-047) Population Pharmacokinetics and Exposure-Response Analysis of Nivolumab in Combination with Ipilimumab in Participants with First-Line Unresectable or Advanced Hepatocellular Carcinoma to Support Benefit-Risk Assessment

(S-048) Exposure-Response Analyses of Dato-DXd in patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer

(S-055) Population Pharmacokinetics of Elranatamab in Chinese Patients with Relapsed or Refractory Multiple Myeloma using PRIOR Approach

(S-058) Concentration-QTcF Analysis Indicates Casdatifan Does Not Prolong QTcF

(S-059) Population Pharmacokinetic, Exposure-Response, and Time-To-Event Analyses of Probenecid in Symptomatic, Non-Hospitalized Patients with COVID-19

(S-075) Exposure-Overall Survival Analysis for Quizartinib in Newly Diagnosed Patients with FLT3-Internal-Tandem-Duplication-Positive Acute Myeloid Leukemia

(S-076) Exposure-Response Characterization of the Safety Profile for a Novel KAT6 Inhibitor, PF-07248144, For Use In Dose Optimization During a Phase 1 First-in-Patient Study

(S-077) Population Pharmacokinetic & Exposure-Response Analysis After Subcutaneous Administration of Guselkumab in Pediatric Participants with Moderate to Severe Plaque Psoriasis

(S-082) Model-Based Approach to Support Nivolumab Subcutaneous Dose Selection in Pediatric Patients (12 to <18 Years) in Multiple Solid Tumor Indications

(S-083) PKPD investigation of BI-S across blood-ocular barrier

(S-084) Population pharmacokinetic modeling of anti-B7H4 antibody-drug conjugate (SGN-B7H4V) in patients with advanced solid tumors from phase 1 study

(S-089) Use of population time-activity curve modeling and simulation to support the reduced tumor dosimetry collection timepoints in radioligand therapy (RLT) clinical trials

(S-090) An Empirical Drug Autoinduction Model to Characterize the Population Pharmacokinetics of TEV-56286 (Emrusolmin) in Healthy Participants and Patients

(S-091) Use of the Animal Rule to Develop JST-010 for Pre-Exposure Prophylaxis Against Infection by Yersinia pestis

(S-096) Real-world Data Driven Pediatric Dose Extrapolation: A Novel Model-informed Drug Development Approach

(S-098) Population Pharmacokinetic Modeling of Rezpegaldesleukin after Subcutaneous Dosing to Account for Variability Across Multiple Patient Populations with Autoimmune Diseases

(S-100) Understanding How Low Calorie Sweeteners Pass from Mother to Infants Through Breastmilk – Insights from Population Pharmacokinetic Modeling

(S-101) A Population Pharmacokinetic Approach to Prospectively Assess Vancomycin Pharmacokinetics in Adult Jordanian Patients: a Step towards Personalized Dosing

(S-102) Mathematical Modeling to Optimize Receptor Occupancy Assay Development for Isatuximab

(S-103) Model-Informed Oral Tacrolimus Dose Optimization for Adult Recipients of Allogeneic Hematopoietic Cell Transplantation Receiving Post-Transplant Cyclophosphamide

(S-105) POPULATION PHARMACOKINETIC (POPPK) MODELING OF IRINOTECAN AND SN38 IN PARTICIPANTS WITH METASTATIC COLORECTAL CANCER (MCRC) IN PHASE 2 AND 3 STUDIES: A SEQUENTIAL PARENT-METABOLITE MODEL

(S-106) Clinical PK characterization of EGT710, a novel coronavirus Mpro inhibitor, and simulation of target attainment rates for efficacious dose prediction

(S-107) Semi-Mechanistic Model for LNP-mediated In-vivo CAR T-Cell Engineering and B-Cell Depletion in Primates

(S-108) Impact of Misspecified Residual Error Model for Heavy-Tailed Error Distribution on PK Model Parameter Estimates

(S-109) Mixed Effects Modeling of Diurnal Cortisol Dysregulation in Long COVID

(S-110) Simulating Relative Infant Hydroxyurea Dose Through Breastfeeding Using a Semi-Mechanistic Population PK Model

(S-111) Re-Purposing Bispecific Antibodies in Autoimmune Diseases: MIDD Based Dose Optimization Strategies

(S-112) Sparse Sampling Strategies for Monoclonal Antibody Pharmacokinetics: Evaluating Estimation Methods for Reliable Clearance Assessment

(S-113) Population pharmacokinetic analysis of sertraline in pregnant individuals

(S-114) A Bayesian Population Pharmacokinetic Analysis of Oritavancin in Pediatric Patients with Skin Infections

(S-115) Population PK/PD Modeling to Optimize Dosing of BIIB107, an Anti-Alpha-4 Integrin Monoclonal Antibody

(S-116) A Novel Bayesian Adaptive Design for Phase I Dose Escalation with Improved Efficiency and Accuracy in Estimation of Maximum Tolerated Dose

(T-001) Optimization of Ponsegromab PK/PD Assessments in Phase 3 Studies by Clinical Trial Simulation

(T-002) Concentration-QTc modeling for ponsegromab using pooled data from 3 phase 1 studies in healthy participants

(T-003) Simultaneous Modeling of Ponsegromab PK, PD and Clinical Response in Patients with Cancer Cachexia

(T-004) Continuous infusion simulations in PBPK and QSP models reveal steady-state properties and rate-limiting steps.

(T-018) Constrained Multi-Objective optimization population PK model selection in NLME and RDarwin.

(T-019) Application of NSGA-II and pyDarwin in Multi-objective Optimization for Population Pharmacokinetic (PopPK) Model Selection

(T-020) Comparison of Machine Learning and traditional Population Pharmacokinetic of Gabapentin in Neuropathic Pain

(T-022) Using Population Pharmacokinetics and Simulation to Develop SAT-3247 for the Treatment of Duchenne Muscular Dystrophy in Pediatric Patients

(T-029) A Model-Based Meta-Analysis Framework to Predict and Manage ADC-Related Grade 3+ Neutropenia Across Clinical Studies

(T-030) PK/PD/PD Models Enable Quantitative Insights into the Exposure-Efficacy Relationships of Tirzepatide for Treatment of Obstructive Sleep Apnea

(T-031) Zelenectide Pevedotin, a Bicycle Drug Conjugate (BDC®), Does Not Present Clinically Meaningful QT Prolongation Risk as Demonstrated by A Concentration-QTc (C-QTc) Analysis

(T-032) Navigating Challenges in Dose-Exposure-Response Analysis in the Presence of Confounding Associated with Titrated Drug Regimens

(T-033) Practical PK/PD Modeling of Lymphocytes and CD4+ T Cells in HIV Patients Treated with the Nucleoside Reverse Transcriptase Translocation Inhibitor (NRTTI) Islatravir

(T-046) Population Pharmacokinetics of Subcutaneous Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

(T-047) Development of Dosing Selection Strategy for Brain Penetrants

(T-049) Monte-Carlo simulations to assess isavuconazole probability of pharmacokinetic-pharmacodynamic target attainment (PTA) for Chinese pediatric patients with invasive aspergillosis (IA) or invasive mucormycosis (IM)

(T-050) A Mechanistic Pharmacokinetic-Pharmacodynamic Model Framework for Degrader-Antibody Conjugates

(T-059) Characterizing the Exposure–Response Relationship of MK-2060 in Participants with End Stage Kidney Disease Receiving Hemodialysis

(T-060) Clinical Utility Index Leveraging Results From Clinical Trial Simulation for Safety and Efficacy Outcomes Derived From Longitudinal Models

(T-061) A semi-mechanistic PKPD model of CSL112 harmonizes the differential cholesterol efflux capacities (CEC) of high-density lipoprotein across different dose groups

(T-062) Exposure-Response Analysis of Guselkumab in the Maintenance Phase in Adults with Moderately to Severely Active Ulcerative Colitis

(T-063) Pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation of a Novel, Directly Acting Antiviral, BDGR-251, in EEEV Infected Mice

(T-068) Model selection for precision dosing: Comparison of Machine Learning and Evidence-plus-Expertise Algorithms

(T-069) Simplifying the Communication of Covariate Effects from Pharmacometric Models - The Role of Unconditional Covariate Effects

(T-071) Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Size Dynamics in Lorlatinib-treated Patients with Non-small Cell Lung Cancer

(T-072) Population pharmacokinetic model-informed dose selection for exogenous hemopexin (CSL889) in patients with sickle cell disease

(T-073) A PK/PD Model to Evaluate Uricosuric Clinical Efficacy versus Therapeutic Window for Treatment of Gout

(T-074) Pharmacokinetic and Exposure-Response Modeling Support Body Surface Area-Based Dosing of Farletuzumab Ecteribulin in Patients with Solid Tumors

(T-077) Comparison of Population Pharmacokinetic Platforms, Monolix and Phoenix for Cephalexin in Infants

(T-078) Exposure-Response Modeling of Efficacy and Safety Endpoints of Sarilumab in Pediatric Patients with Polyarticular-Course Juvenile Arthritis

(T-080) Population Pharmacokinetic/Pharmacodynamic Modeling and Analysis of Tetrahydrobiopterin and Blood Phenylalanine Response in Adult and Pediatric Patients with Phenylketonuria During Sepiapterin Treatment

(T-081) A Population PK Approach to Evaluate Plasma and ELF Exposure Changes Following Co-administration of Spectinamide 1599 and Pyrazinamide in Mice

(T-082) Population PK and PK/PD Modeling of Apitegromab in Spinal Muscular Atrophy Patients

(T-083) Exposure-Response Analysis of Guselkumab in Induction Studies in Adults with Moderately to Severely Active Ulcerative Colitis in the QUASAR Program

(T-084) Population Pharmacokinetics of Deutetrabenazine in Asian Individuals

(T-085) Pharmacometric Modeling of Clazakizumab in Patients Undergoing Maintenance Dialysis

(T-087) Exposure-Response Analysis of Bleeding Events Following Weekly SC Flat Dose Marstacimab Administration in Hemophilia Participants Using Regression Modeling and Repeated-Time-To-Event (RTTE) Analyses

(T-088) A Mechanistic Pharmacokinetic/Pharmacodynamic Model for CD19 Targeting Therapies for Autoimmune Diseases

(T-093) Adjusted Ideal Body Weight Dosing Reduces Pharmacokinetic Variability of the PD-L1 Targeted Antibody-Drug Conjugate PDL1V (PF-08046054)

(T-094) Population Pharmacokinetics of Brensocatib in Adult and Adolescent Patients with Non-Cystic Fibrosis Bronchiectasis (BE)

(T-095) Pharmacokinetic Modeling of Prophylactic Dose Rivaroxaban Transfer into Human Milk

(T-097) Development of a Combined Deposition–Physiologically Based Pharmacokinetic Model for Inhaled Treprostinil in Idiopathic Pulmonary Fibrosis

(T-099) Joint modeling of serum M-protein and PFS to predict response to isatuximab in combination with bortezomib/lenalidomide/dexamethasone in newly diagnosed multiple myeloma patients

(T-100) Exposure-Response Analysis of Datopotamab Deruxtecan (Dato-DXd) in Combination with Pembrolizumab with or without Platinum Chemotherapy in Patients with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

(T-101) Comparison of Predictive Performance of Complex IS/ID and Simple KPD Models on durability projections of Neutralizing Antibodies of LNP-mRNA-Based Vaccines

(T-102) Methylprednisolone PK/PD in a Rat Model of Cytokine Release Syndrome

(T-104) Population Pharmacokinetics of Dexmedetomidine in Neonates with Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia: Insights from a Prospective Real-World Study

(T-105) Characterizing Chimeric Aducanumab Disposition in a Preclinical Alzheimer’s Model Using Population PK Modeling

(T-107) Use of Emtricitabine-Triphosphate Concentrations in Dried Blood Spots to Evaluate Pre-Exposure Prophylaxis (PrEP) Adherence

(T-108) Right Dose, Wrong Patient? Clinical Perspectives on Atomoxetine Nonresponse in ADHD

(T-109) A Multi-route, Multi-formulation Population Pharmacokinetic Framework for THC and 11-OH-THC Reflecting Real-World Use

(T-110) PK/PD Modeling of Dexamethasone in Heart and Lung Tissues in an Animal Model of Cytokine Release Syndrome

(T-111) Population Pharmacokinetics of Levocetirizine in Children with Uncontrolled Allergic Asthma: An Ongoing Study

(T-112) Early sampling improves voriconazole target attainment in pediatric patients dosed with model-informed precision dosing tools: a simulation study

(T-113) Model-informed Evidence Generation to Optimize Warfarin Dosing for Hepatic Impairment