Preclinical and Translational Sciences - Biomolecular

(W0930-10-63) Alternative Approach to Demonstrate Bioequivalence of Generic Formulations of Sucralfate Oral Suspension

(M0930-10-63) Physiologically Based Pharmacokinetic (PBPK) Modeling of Fexofenadine and Assessment of Transporter DDIs of Fexofenadine with P-gp Inducers and Inhibitors

(W0930-10-64) A Science-Based Approach for Recommendation of Antagonist Blockade in the Bioequivalence Studies of Opioid Drug Products

(M0930-10-64) Quantification of Oligonucleotide Therapeutics in Plasma Using a Generic Kit-Based Approach

(W0930-10-65) Bioavailability and Local Immunogenicity after Subcutaneous Administration of Therapeutic Proteins: Mechanistic Modelling within the Open Systems Pharmacology Framework

(M0930-10-65) Prospectively Assessing the Immunogenic Risk of Potential Synthetic Peptide Impurities In Silico Using the What-if Machine (WhIM)

(W0930-10-66) Leveraging Nausea Exposure-Response Relationship to Optimize Titration and Dose Selection Decisions for Cotadutide

(M0930-10-66) Masking Strategies for Immune Checkpoint Inhibitors to Decouple Adverse Events in Cancer Treatment

(W1030-10-63) Atraumatic Access to Xenograft Human Glioblastoma by Cerebral Open Flow Microperfusion

(M1030-10-63) In Vitro and In Vivo Pharmacokinetics of a Novel B7-H3 Inhibitor (Ni1) for the Treatment of Group 3 Medulloblastoma

(T1030-10-63) Predictive Power and Operational Use of SCISSOR to Streamline SC Biologics Drug Development

(M1030-10-64) Concentrations and Causal Confounding: Choosing Exposure Measures with Care When Constructing an Exposure-Response Analysis

(T1030-10-64) Mathematical Modeling-Based Calibration-Free Estimation of Receptor Expression and Binding Kinetics of Antibody Biotherapeutics Based on Time Evolution of Fluorescence Profile

(T1030-10-65) A Review of Immunogenicity and Its Effect on Efficacy and Safety of Biologics as Reported on the Prescribing Label to Support Strategic Assessment and Planning Labeling Communications

(M1030-10-65) Clinical Correlation of Conventional Allometric Scaling Approach for PK Predictions of FcRn Enhanced and Protease Resistant Long-Acting mAbs, TAVO101 and TAVO103

(M1030-10-67) Determination of the Concentration of the Drug MG1113 in Human Sodium Citrate Plasma Using a Sandwich Electro Chemiluminescent Immunoassay (ECLIA)

(W1030-10-67) Pharmacokinetics of Biologics in Obese Rats

(W1030-10-68) In Vitro and In Vivo Potency of a Highly Efficient Cocaine Hydrolase and Its Long-Term Stability

(M1130-10-65) A Next Generation Mathematical Model for the In Vitro to Clinical Translation of T-Cell Engagers

(T1130-10-65) A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Relative Bioavailability Study of Omaveloxolone Intact Capsules versus Capsule Contents Sprinkled on Applesauce in Healthy Adult Subjects

(W1130-10-66) Multiscale Modeling-Identified Synergistic Combinations of Anti-microRNA-155 and Standard-of-Care Drugs for Improved Outcomes in Non-small Cell Lung Cancer

(T1130-10-68) EGFR-Targeted Nanoliposomes of Synergistic Oncogenic Protein Degrader Combination: Significant Inhibition of Tumor Growth in Lung-Tumor Bearing Mice

(M1130-10-68) Influence of Bovine Serum Albumin on Colonic Mucus Permeation and Solubility of Celecoxib and Naproxen in Fasted State Simulated Colonic Fluids

(M1230-10-63) Characterization of Preclinical In Vitro and In Vivo Pharmacokinetics Properties for JNJ-64619178, a New Therapeutic for the Treatment of Medulloblastoma

(W1230-10-64) COG133-Targeted Polymeric Nanoparticles Encapsulating PLK-1 Inhibitor Blocks DNA-Damage Repair Pathways to Sensitize Medulloblastoma Cells for Radiotherapy

(M1230-10-64) PBPK Modeling Coupled with Biorelevant Dissolution to Forecast the Oral Performance of Amorphous Solid Dispersion Formulations

(T1230-10-65) A Survey of Prevalence of Pediatric Dosing for Biologics

(W1230-10-66) A Novel Approach to Harvest Human Mucus on RepliGut® Planar Platform for Research Related to Gastrointestinal Tract and Its Associated Disorders, along with Drug Delivery Studies

(M1230-10-68) Ultrasmall Nanoprobes for Fluorescence-Guided Surgical Resection of Peritoneally Disseminated Tumors

(M1230-10-69) Population Pharmacokinetics of Enrofloxacin and Florfenicol in the Giant Danio (Devario aequipinnatus) following Oral and Bath Administration

(M1330-10-63) Effect of pH on Metabolite Profiling and Identification of GalNAc Conjugated siRNA in In Vitro Metabolic System

(T1330-10-64) Advancing Neuro-Regenerative Therapies: Scalable Manufacturing and Purification of Extracellular Vesicles for Treating Neurodegenerative Diseases

(M1330-10-64) Evaluation of In Vitro Protein Binding of STK-001, an Antisense Oligonucleotide, in Plasma and Cerebrospinal Fluid

(M1330-10-65) Quantifying Clinical Trial Diversity of New Drugs Approved by the FDA

(T1330-10-65) Tocilizumab Induced Immunosuppression in A Case of Adult-Onset Still’s Disease: Are These Newer Biologics Double Edged Sword?

(M1330-10-66) Case Study: Assessing Innovator vs. Biosimilar mAb Stability to Minimize Immunogenic Risk

(M1430-10-63) Assessing In Vitro Release Testing (IVRT) in Bioequivalence Studies for Complex Products - Considerations for Ophthalmic versus Topical Dermatological Dosage Forms

(M1430-10-65) Comparing a t-Distribution Based Bayesian Approach with the Two One-Sided t-Test (TOST) for Bioequivalence Studies in Real-World Datasets

(T1430-10-65) Novel Biomarkers for Inflammatory Bowel Disease

(M1430-10-66) Assessment of In Vitro and In Vivo Pre-clinical Pharmacokinetics of EPZ015666; a Novel Small Molecule for Medulloblastoma Treatment

(T1430-10-67) Butyrate Drives Metabolic Rewiring and Epigenetic Reprogramming in Human Colon Cancer Cells

(T1530-10-63) Prediction of Human PK for Multispecific Antibody TAVO412 Using Non-linear Population PK Model and Allometric Scaling

(M1530-10-63) Quantum Electrochemical Spectroscopy (QES): A Novel Approach for Enhanced Detection and Evaluation of Drug-Induced Liver Injury (DILI)

(T1530-10-64) Comprehensive Assessment of Immunogenicity Risk of Host Cell Proteins in Biologics Using In Silico and In Vitro Methods

(M1530-10-64) Repeatability and Reproducibility of Simulated Fasted and Fed State Gastrointestinal Conditions and Paracetamol Bioaccessibility in the Dynamic In Vitro Models TIM-1 and Tiny-TIMsg

(T1530-10-65) Artificial Extracellular Matrices Containing Human Collagen for In Vitro Analysis of Formulations Intended for Subcutaneous Injection

(M1530-10-65) Transforming Growth Factor-Beta (TGF-β) as a Potential Therapeutic Target of Methylseleninic Acid and Seleno-l-Methionine in Clear Cell Renal Cell Carcinoma

(T1530-10-66) A Regression Approach for Assessing Large Molecular Drug Concentration in Breast Milk

(M1530-10-66) Next Level Drug Research in an Ex Vivo Tissue Gut-on-a-Chip Model: Advanced Applications of the Intestinal Explant Barrier Chip (IEBC)