Preclinical, Clinical, and Translational Sciences

(W0930-05-27) Decellularization of Porcine Bladder as a Biocompatible Platform for Evaluating In Vitro Drug Efficacy

(M0930-05-27) In Vivo Preclinical Pharmacokinetics of Nortriptyline and Its Application to Develop a Physiologically Based Pharmacokinetic Model

(T0930-05-27) Toward Disease-Specific Digital Twins of Ex Vivo Human Lungs for Restrictive and Obstructive Lung Diseases Using Machine Learning

(T0930-05-28) Cellular Mechanisms Underlying Species-Related Differences in Effective Delivery of LNP-mRNA

(W0930-05-28) Exploring the Effects of Nano-Enabled Oral Insulin and Anti-Inflammatory Agent in Mitigating Diabetic Ocular Complications in Type 2 Diabetic Rat Model

(M0930-05-28) In Vitro ADME, Mouse Pharmacokinetics, and Bioanalysis of LD14b: A Novel Aβ 17β-HSD10 Modulator for the Treatment of Alzheimer’s disease

(W0930-05-29) Pharmacokinetic Differences of Paclitaxel and Cyclopamine in Healthy and HCC Mice when Co-administered via Polymeric Micelle and Cremophor EL

(M0930-05-29) Sustained Drug Exposure Drives Efficacy: PK/PD Analysis of Corallopyronin A against Wolbachia Using Physiologically Based Biopharmaceutic Modeling

(T0930-05-29) Transdermal Delivery of Enfuvirtide Using Dissolving Microneedles Integrated with Insertion and Removal Indicator

(W0930-05-30) Machine-Learning-Based Assessment of Breast Tumor Malignancy Through Nuclear Morphological Features

(M0930-05-30) PBPK-Based Prediction of Obesity-Mediated Changes in Small Molecule Pharmacokinetics

(M0930-05-31) Model-Informed Precision Dosing of Riluzole in Acute Spinal Cord Injury Using Pharmacokinetic, Pharmacodynamic, and Clinical Outcome Modeling

(T0930-05-31) Non-invasive In Vivo Imaging of β-Cell Function in the Rodent Pancreas Using a Zinc-Responsive Contrast Agent

(W0930-05-31) User-Friendly Web Applications for Pharmacokinetic Simulations and Predictions

(T0930-05-32) A Mechanistic Framework for PBPK Modelling of the Impact of Osmotically Active Species, including Excipients, on Oral Drug Absorption: The Underlying Mechanistic Model

(M0930-05-32) Nonparametric Superposition and Simulation to Predict Recommended Dosing of Ecopipam for Patients with Various Degrees of Chronic Hepatic Insufficiency

(M0930-05-33) A Gut-Hepatobiliary Organ Perfusion Model: Demonstrator Study Showing the Absorption, Metabolism, and Excretion of Midazolam

(T0930-05-33) Direct Diffusion–Driven Salivary Gland Accumulation of Buprenorphine Following Sublingual Administration Promotes Dental Caries

(M1030-05-27) Charge-Tunable Synergistic Nanotherapeutics for Lung Cancer: Reactivating Tumor Suppressor p53 While Inhibiting DNA Synthesis

(T1030-05-27) Tamoxifen and Metabolite Effects on Cellular Metabolism in Pancreatic Cancer Cell Lines

(T1030-05-28) Enhanced Intravitreal Pharmacokinetics in the Simcyp™ Ocular Model

(M1030-05-28) Genetically Engineered Multifunctional Immune-Modulating Exosomes (GEMINI-Exos) for Colorectal Cancer Treatment

(M1030-05-29) Evaluation of Pharmacokinetic Characteristics and the Food Effect of Radotinib in Healthy Volunteers

(T1030-05-29) Population Pharmacokinetic Modeling of Rezpegaldesleukin after Subcutaneous Dosing to Account for Variability Across Multiple Patient Populations with Autoimmune Diseases

(M1030-05-30) Modelling and Simulation of Fentanyl Matrix Patches and Risk Assessment from Manufacturing Errors

(T1030-05-30) Toward a Physiologically Based Pharmacokinetic Model for Topical Ophthalmic Suspension

(T1030-05-31) Harnessing a Cutting-Edge Time-Lapse Flow Cytometry Platform for Enhanced Immunogenicity Assessment

(M1030-05-31) Maintaining Liver Viability, Functionality and Metabolic Capacity During Multi-Day Machine Perfusion

(T1030-05-32) Gender Differences in the Pharmacokinetics, Tissue Distribution and Metabolism of a Potent Pulmonary Arterial Hypertension Therapeutic Drug ZEX in Mice

(M1030-05-32) Synthesis, Characterization, and Stability of Iron-Chlorophyll Derivatives (ICDs)

(M1030-05-33) AI-Enhanced Regulatory Inspection Platform: A Multi-Modal System for Automated Report Generation and Compliance Assessment

(M1130-05-27) Brain Mitochondrial Metabolic Alterations In VCD-Induced Menopause Model

(T1130-05-27) Characterizing Population Variability in Vaccine-induced Immunity: A Machine Learning Integrated Mechanistic Modeling Approach

(M1130-05-28) Clay Attenuates Diarrhea Induced by Fat in a Mouse Model

(T1130-05-28) Toward IVIVC (In Vitro-In Vivo Correlation) for Glycosidic Compounds: Optimization Study of β-Glucosidase Addition Levels in Membrane Permeation Tests

(T1130-05-29) Integrating Targeted Proteomics and Ocular Pharmacokinetics to Support PBPK Modeling of Carboxylesterase-Mediated Drug Metabolism in the Eye: A Case Study with Latanoprost Ophthalmic Solution

(M1130-05-29) Optimization and Application of an In Vitro Direct Contact Neurovascular Unit Model to Assess Neurotoxicity

(M1130-05-31) A Mathematical Model Describing the Activity of Proton Gradient-Driven MATE Transport

(T1130-05-31) Combining Biorelevant Dissolution, Machine Learning, and PBBM to Explore Drug Exposure Variability due to Gastric Contractions and pH: A Case Study of Dabigatran Etexilate Capsules

(T1130-05-32) Acoramidis Improved Clinical Outcomes, Function, Quality of Life and NT-proBNP in Patients with Transthyretin Amyloid Cardiomyopathy Regardless of Atrial Fibrillation Status at Baseline

(M1130-05-32) Fatigue Forecasting in Long COVID Using Wearable Heart Rate Variability Monitoring

(T1130-05-33) Drug Tolerance Enhancement in a Ligand Binding Neutralizing Antibody (NAb) Assay using Affinity Extraction

(M1130-05-33) Physicochemical and Biopharmaceutical Characterization of Locally Bioavailable COX-2 Inhibitor for Familial Adenomatous Polyposis

(M1230-05-27) CCR5 Receptor Targeted Lipid Nanoparticles for HIV-1 Proviral DNA Excision

(T1230-05-27) Human Pharmacokinetics Prediction for Trastuzumab Using Scaling and Two-Compartment Modeling with B-hFcRn Mice PK Data

(M1230-05-28) Acoramidis Reduces All-Cause Mortality and First Cardiovascular Hospitalization in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from the ATTRibute-CM Study

(T1230-05-28) Characterization of an Inhouse Developed Human Hepatocyte Co-culture Model for Evaluating Induction of Cytochrome P₄₅₀ CYP2C Enzyme Family

(M1230-05-29) Formulation Development of Extemporaneously Prepared Mucoadhesive In Situ Forming Gels for Oral Mucositis Pain Control

(T1230-05-30) Sensory Panel Tests for Topical Semi-Solid Creams: Correlation between Sensorial Perceptions and Product Critical Quality Attributes

(T1230-05-31) Hepatocyte Uptake Assay to Improve IVIVC Disconnects of Lipophilic Acids

(M1230-05-31) Physiologically Based Biopharmaceutics Modeling of Formulation Bioequivalence for Mobocertinib, a Weak Base, Using pH-Dependent Dissolution Data

(M1230-05-32) 2024-2025 FDA 505(b)(2) Drug Approvals: Insights into Pharmaceutical Products and Their Reformulation Challenges and Therapeutic Indications Trend

(T1230-05-32) Acoramidis Lowers NT-proBNP in a Larger Proportion of ATTRibute-CM Study Participants with Transthyretin Amyloid Cardiomyopathy Compared with Placebo, Independent of Atrial Fibrillation Status

(T1230-05-33) Integrated Evaluation of Mechanistic Population PK and Exposure-Response for Dose Justification of Glecirasib in NSCLC Patients with KRAS G12C Mutation

(M1230-05-33) Serum Transthyretin Levels at Day 28 are Associated with Cardiovascular Outcomes: Insights from the ATTRibute-CM Study

(T1330-05-27) Exposure-Response Relationships of Radotinib Assessed in Patients with Chronic Myeloid Leukemia

(M1330-05-27) Tolerogenic Form of FVIII Provides Durable Tolerance in Hemophilia A Mice Following 3 Months of Treatment

(M1330-05-28) Acoramidis Effect on All-Cause Mortality in Patients with p.V142I (V122I) Variant ATTR-CM: Findings from the ATTRibute-CM Study

(T1330-05-28) Analyzing the Influence of Target-Mediated Drug Disposition (TMDD) on Affinity Binding Dynamics in an investigational mRNA Therapeutic Encoding a Human Monovalent Antibody

(M1330-05-29) Predicting Aflibercept Local Exposure in Humans Using an Ocular PBPK Model

(T1330-05-30) Validation of a Colorimetric Enzyme Cell-Based Assay for the Detection of Neutralizing Antibodies to IL-2 in Human Serum

(T1330-05-31) Anti-Tumor Efficacy, Safety, and Ongoing Pharmacokinetic Evaluation of Nebivolol in a Syngeneic Mouse Model of Triple-Negative Breast Cancer

(M1330-05-31) Local Delivery of Recombinant Human CST6 Protein and Human CST6-Coding mRNA for Bone Regeneration

(T1330-05-32) DrugChat: An Intelligent AI Agent for Herb-Drug Interaction Queries

(M1330-05-32) Simulating Prodrug Biotransformation In Vitro: Conserving Enzymatic Activity within the SCISSOR N3 Platform

(M1330-05-33) Chemotherapy and Acute Lymphoblastic Leukemia–Induced Liver Fibrosis is Associated with the eIF2α Stress Response Pathway and ATGL Activation

(M1430-05-27) Integration of a Novel First-Order Release Z-Factor Dissolution Model with Global Sensitivity Analysis to Guide Formulation Development Using Physiologically-Based Biopharmaceutics in OSPSuite v12

(T1430-05-27) Physiologically Based Pharmacokinetic Modeling to Inform Lenacapavir Dose Regimen when Co-Administered with Rifamycins in Participants with Tuberculosis

(M1430-05-28) Assessing Gastric Emptying of Gastro-Resistant Capsules in Pigs: Impact of Capsule Size

(T1430-05-28) Utilizing PBPK Modeling in GastroPlus to Explore the Pharmacogenetics of Gisenoside Rd

(M1430-05-29) Exposure-Response Analysis of Nervonic Acid and C26:0-Lysophosphatidylcholine in an Adrenoleukodystrophy Mouse Model - Therapeutic Implications

(T1430-05-29) Real-World Comedication in Cognitive Impairment Associated with Schizophrenia (CIAS): Translating Data into Drug-Drug Interaction (DDI)-Aware, Patient-Centered CNS Drug Development

(T1430-05-30) Effect of Semaglutide on Muscle Mass Loss in Rats on a High-Fat Diet

(M1430-05-30) From In Vitro Dissolution Testing to In Vivo Clinical Pharmacokinetic Prediction Using PBPK Models for Oral Cavity Drug Products

(T1430-05-31) ddPCR-Based Assessment of Dendritic Cell Activation for Immunogenicity Evaluation

(M1430-05-31) Development and Application of PBPK Models for Cariprazine and Its Active Metabolites to Predict CYP3A-Mediated Drug-Drug Interactions and Inform Dose Adjustment Strategies

(T1430-05-32) Co-Modeling of Re (CO)₃-Phenformin and Phenformin in Whole Blood and Tissues after Dosing of Re (CO)₃-Phenformin in Mice with Validated LC-MS/MS Assay

(M1430-05-32) Prediction of Human Volume of Distribution Using Animal PBPK Modeling and Simulation with Octanol-Water Partition Coefficient or Tissue-to-Plasma Partition Coefficient Scaling

(M1430-05-33) Rapid Systemic Absorption of an Immediate-Release Ilaprazole-Sodium Bicarbonate Fixed Dose Formulation Comparable to a P-CAB: A Preclinical Pharmacokinetic Study

(T1530-05-27) Analytical Method Development and Characterization of a Novel Antimicrobial Peptide WW504 In Vitro and In Murine Tissues by LC-MS/MS

(M1530-05-28) Piperazine Based Lipid Nanoparticles Facilitate Enhanced Endosomal Escape and CRISPR-Cas9 Mediated HIV-1 Proviral DNA Excision

(T1530-05-29) A Breakthrough Predictive Framework for High-Precision Estimation of the Heat of Vaporization in Lipid-Based Drug Delivery Systems

(M1530-05-29) Sample Analysis of a Multidomain Fusion Protein Drug with Linker Peptides: Tiered Domain Characterization of Neutralizing and Anti-Drug Antibodies in Correlation to Pharmacokinetic Profiles

(T1530-05-30) Nonparametric Superposition and Simulation to Predict Recommended Dosing of Ecopipam for Patients with Various Degrees of Chronic Renal Insufficiency

(T1530-05-31) Exposure Response Assessment of a Novel, Directly Acting Antiviral, BDGR-251, in EEEV Infected Mice

(M1530-05-31) Oral Targeted Delivery of MLY2/MLY8 via Lipid Nanoparticles for Refractory Ulcerative Colitis

(T1530-05-32) A Novel Approach to Preclinical Drug Development Using Digital Twins of Ex Vivo Human Lungs

(M1530-05-32) Effect of Mucin on Drug Dissolution in Lipid–Surfactant Systems During Digestion

(M1530-05-33) Effectiveness of Droplet Digital PCR (ddPCR) and Hybridization (ECLIA) for Bioanalysis and Biodistribution of Gene Therapy Products