Preclinical, Clinical, and Translational Sciences

(M0930-02-07) Comparative Analysis of Pharmacokinetics and Drug-Drug Interactions in Microdosing Cocktail Studies Using Physiologically-Based Pharmacokinetic Modeling

(T0930-02-07) Evaluation of the Effect of Food and Gastric pH Change on the Pharmacokinetics and Safety of Imlunestrant in Healthy Volunteers

(W0930-02-07) Revolutionising Microneedle-Based Transdermal Delivery: A Colourful Approach to Efficiency Feedback and User Navigation

(M0930-02-08) Evaluation of Amorphous and Lipid-Based Formulation Strategies to Increase Oral Cannabidiol Bioavailability

(W0930-02-08) Lumbar Intrathecal Infusion of an siRNA Formulation via Cannulation in Rats Demonstrated Comparable Tissue Distributions and Improved Animal Response as Comparing to Non-Cannulated Free Hand Method

(T0930-02-08) The Influence of Silica Nanoparticles with Varied Physicochemical Properties on the Immune Function of RAW 264.7 Macrophages

(T0930-02-09) Development of Dihydromyricetin for Effective Oral Dosing

(M0930-02-09) Predicting Bioequivalence with the COMPASS Tool - Analysis of the Experimental and Literature Data

(W0930-02-09) Toxicokinetics of MEB-1170, a mu-Opioid Receptor Agonist, in Dogs in a 28-Day Oral Toxicity Study

(W0930-02-10) Evaluation of the Disposition and Absolute Bioavailability of Imlunestrant in Healthy Volunteers

(M0930-02-10) Multiplexed Cytokine Measurements in Culture Supernatants upon Ex Vivo Stimulation of Human PBMCs to Assess Cellular Immune Response in Vaccine Studies

(T0930-02-10) PK/PD Relationship of a Promising Protein Drug Candidate (CocH5-Fc(M6)) and Its Efficacy in Blocking Cocaine Discrimination in Rats

(T0930-02-11) Delineating the Role of Transporters in the Absorption and Disposition of Digoxin Using the Physiologically Based Pharmacokinetic (PBPK) Modeling

(M0930-02-11) Toxicokinetics of 23ME-01473, a Novel Anti-ULBP6/2/5 Monoclonal Antibody, in Cynomolgus Monkeys Following Intravenous Bolus Injections in a 4-Week Toxicity Study

(W0930-02-11) VLX-1005 Multiple Ascending Dose Pharmacokinetics

(T0930-02-12) A PBPK Model to Simulate Intranasal Naloxone Rescue from Fentanyl Overdose

(W0930-02-12) Oral Tolerance Mediated by Phosphatidylserine Containing Lipid Nanoparticle

(M0930-02-12) Sex, Racial, and Ethnic Representation in COVID-19 Vaccine Clinical Trials Conducted in US - A Systematic Review Compared to 2020 US Census Data

(W0930-10-54) Comparative In Vitro Release and Clinical Pharmacokinetics of Leuprorelin Depot 3.75mg, a One-Month Sustained-Release Formulation of Leuprorelin Acetate

(T0930-10-54) Evaluation of PBPK Modeling in Predicting the Distribution and PK of Targeted Protein Degraders in Preclinical Species

(M0930-10-54) Utilization of Proteomic Surrogates for Early Detection of Unexpected Drug Benefits

(W0930-10-55) Development of a Sensitive, Drug Tolerant Total Antibody Assay for the Detection of Antibodies against a Novel Capsid AAVPRV in Human Serum and CSF

(M0930-10-55) Protective Effects of Angiotensin Receptor Blockers on Knee Joint Cartilage Volume: A Retrospective Analysis of Osteoarthritis Initiative Study

(T0930-10-56) Current Drug Substance Stability Issues Related to the Biopharmaceutics Classification System (BCS) Class III -Based Biowaivers in Abbreviated New Drug Applications (ANDAs)

(M0930-10-56) Evaluating Food Effects in Oral Drug Delivery Using a Combination of PBPK Modeling and Molecular Dynamics Simulations

(W0930-10-56) Leveraging Cross-Species Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling to Drive Discovery Efforts of a Novel Protein Degrader

(M0930-10-57) Open Label, Single Center, 2 Part Parallel Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of [¹⁴C]E7386 in Healthy Male Subjects

(W0930-10-57) Orforglipron Weight Loss and Nausea Accurately Simulated with OBESITYsym

(T0930-10-57) Predicting Pharmacokinetic Response of Small Molecules in Rats via Machine Learning

(M0930-10-58) Protein Engineering Strategies to Overcome High Target-Independent Clearance of Monoclonal Antibodies Due to Charge-Driven Liabilities

(W0930-10-58) Translational Research to Facilitate Development of Novel Therapeutic Combination of Letrozole with a CDK 4/6 Inhibitor Ribociclib for the Treatment of Glioblastoma

(T0930-10-59) In Vitro and In Vivo Correlations of Danazol-SEDDS Formulations Using MacroFLUX^TM and miniFLUX™

(W0930-10-59) Matrix Comparability Assessment between 3.2% Sodium Citrate and 3.8% Sodium Citrate Human Plasma in PK and ADA Assays

(M0930-10-59) Validation of a Quantitative PCR (qPCR) Assay for the Detection and Quantification of Replication Competent Lentivirus for Patient Monitoring in Lentiviral Vector-Based Cell Therapy Studies

(W1030-02-07) Determination of the Concentration of Monoclonal Antibodies (Mab) Drug in Human Serum Using an Enzyme-Linked Immunosorbent Assay (ELISA)

(T1030-02-07) Pediatric Oral Cavity PBPK Model to Predict Pharmacokinetics of Mucoadhesive Atropine Gel to Treat Sialorrhea

(M1030-02-07) Review of First-in-Human Trials for Gene Therapy in Ocular Diseases

(W1030-02-08) Distribution of Standard-of-Care Antituberculosis Drugs in Cynomolgus Macaque Lungs

(M1030-02-08) Mechanistic Mathematical Modeling of In Vitro Drug Release from PLGA-Based Dexamethasone Solid Implants

(T1030-02-08) The Potential of In Vitro Dissolution Absorption System 2 (IDAS2) as a Bioequivalence Decision Tool

(M1030-02-09) Integration of Gut Microbiome Metabolism in a PBBM-PBPK Model: Its Impact on the Sulfasalazine Absorption

(W1030-02-09) Machine Learning-Based Rational Design of Inorganic Nanoparticles for Improved Safety in Biomedical Applications

(W1030-02-10) Development of a Predictive Model for Vancomycin-Associated Nephrotoxicity Using the Area under the Concentration-Time Curve of Vancomycin: A Machine Learning Analysis

(M1030-02-10) Exploring the Influence of Dietary Components and Excipients on Intestinal Lymphatic Drug Absorption: Findings from an Advanced In Vitro Approach

(T1030-02-10) Modeling-Derived Immune Signature Explains Population-Scale Variability in Vaccine-Induced Immune Response

(M1030-02-11) Demonstration of Virtual Bioequivalence (VBE) Between Progesterone Vaginal Rings Using Mechanistic Vaginal Absorption and Metabolism Model (MechVAM) Within Simcyp Simulator

(W1030-02-11) Immunotoxicity of Silica Nanoparticles as a Function of Physicochemical Properties

(T1030-02-11) Toxicokinetics of NIDO-361, a Potential Candidate to Treat Spinal and Bulbar Muscular Atrophy (SBMA), in Rats and Monkeys Following Oral Dosing in a 13-or 26-Week Toxicity Study

(W1030-02-12) Comparative Detection of Pre-existing Anti‑AAV8 Antibodies in Normal Human Serum by a Total Antibody Assay Versus a Transduction Inhibition Assay

(T1030-02-12) Elucidating the Role of IL-8 in NSCLC: Integrated Analysis Through Imaging Mass Cytometry, Mass Cytometry, and Single-Cell Sequencing

(M1030-02-12) Investigating Differences in the Pharmacokinetics of Monoclonal Antibodies in Japanese and Non-Japanese Subjects

(W1130-02-07) Development and Verification of a Physiologically-Based Pharmacokinetic (PBPK) Model for Vaginal Administration of Progesterone Ring and Gel Formulations

(T1130-02-07) Novel Method of Quantitatively Predicting the Clearance of Uridine Diphosphate-Glucuronosyltransferase Substrates Using Human Liver Chimeric Mice

(M1130-02-07) The Significance of Biotransformation in Discovery Research of NCEs (New Chemical Entity): Examples of Unique Case Studies

(T1130-02-08) In Vitro Selectivity of Several Bile Acid Glucuronides as OATP1B Endogenous Biomarkers

(M1130-02-08) Kinetics of Sutezolid Metabolism to Its Active Metabolite and Identification of the Relevant Drug Metabolizing Enzymes

(M1130-02-09) Deciphering Response Patterns to AKT Inhibitor MK2206 in Breast Cancer Patients: Unveiling Signature Profiles

(W1130-02-09) Maternal Exposure to Kratom Alkaloids: A Comparative Pharmacokinetic Study of Various Kratom Preparations in Pregnant Rats

(T1130-02-09) Pharmacokinetic Characteristics of Radotinib Assessed in Asian Patients with Chronic Myeloid Leukemia

(M1130-02-10) Bivariate Statistical Analyses Reveal the Performance of Human FcRn Transgenic Mouse in Predicting Human Pharmacokinetics of Therapeutic Antibodies

(T1130-02-10) Pharmacokinetic Drug-Drug Interactions of Imlunestrant in Healthy Female Participants of Nonchildbearing Potential

(W1130-02-10) The Advantage and Disadvantage of In Vivo Predictive Dissolution Profiles of BCS Class II Drugs Generated by a Transfer Method and Compendial Method with Different Buffer Species

(T1130-02-11) Cannabinoid Combination Therapy for Doxorubicin Resistant MDA-MB231: Oral Exosome Formulation Versus Parenteral Approaches

(W1130-02-11) Having Appropriate Critical Reagents Can Make Bi-Specific Drug Anti-Drug Antibody Assays Less Challenging and Easy to Specifically Quantify

(M1130-02-11) Toxicokinetics of cNP8, a Fibronectin-Derived Peptides, in Rats and Dogs Following a Single Intravenous Injection in an Expanded Acute Toxicity Study

(M1130-02-12) A Mechanistic Rat PBPK Model for Genistein and Its Glucuronide Metabolite: Integrating Liver and Enteric Metabolism with Transporter-Mediated Biliary and Enteroluminal Clearance

(T1130-02-12) Idasanutlin-Ionizable Lipid Nanocomplex (IDLIN) for Enhanced Solubility, Stability, and Anticancer Activity in p53 Sensitive Lung Cancer

(W1130-02-12) Virtual Bioequivalence (VBE) Outcome May Depend on Choice of Dissolution Inputs in Physiologically Based Pharmacokinetic Modelling

(M1230-02-07) Dispersome® as an Advanced Platform for Oral Bioenhancement

(W1230-02-07) EpiScreen®2.0 Time Course Assay: A Sensitive and Data Rich Tool for Pre-Clinical Immunogenicity Testing of Biologics

(T1230-02-07) Risk-Based Decision Matrix for Identification of High-Risk Pharmaceutical Products that Need a Full-Scale Toxicological Evaluation

(M1230-02-08) In Vitro – In Vivo Correlation Studies of Amorphous and Lipid-Based Oral Cannabidiol Formulations

(W1230-02-08) Multiplexed Assays for Detection of IgG Antibodies against AAV Serotypes

(T1230-02-08) Physiologically Based Pharmacokinetic Modelling of Risperidone and Its Metabolite Paliperidone PLGA Based In Situ Gel Forming Long-Acting Injectable Formulations In Vivo

(M1230-02-09) Comparative Transcriptomic Profiling of Drug Metabolizing Enzymes and Drug Transporters in the Rabbit Ocular Sub-tissues

(T1230-02-09) Examination of the Diffusion Properties of Hydrogels as Optimized Preclinical In Vitro Models for the Human Vitreous Body

(M1230-02-10) No Clinically Meaningful Pharmacokinetic Drug-Drug Interaction Between Berotralstat and the Progestin Oral Contraceptive Desogestrel

(W1230-02-10) Post-Complete Response Letter Scientific Meeting Requests: Key Takeaways from Case Studies

(T1230-02-10) Revisiting Potency Classification of Topical Corticosteroids Using a Standardized Approach Involving Vasoconstrictor Assay (VCA)

(M1230-02-11) Novel Quantification Method for Evaluation of Hair Growth in Mice

(W1230-02-11) Risk Assessment for Extrapolation of Bioequivalence Conclusion from a Male-Only Study Population to the General Population

(T1230-02-11) Toxicokinetics of MEB-1170, a mu-Opioid Receptor Agonist, in Rats in a 28-Day Oral Toxicity Study

(T1230-02-12) Gaps in Non-Binary Populations in Clinical Trial Participation: A Comparative Analysis of Cardiovascular and Solid Tumor Studies

(M1230-02-12) Metabolite Identification of a Kratom Alkaloid Speciogynine in Human Liver Microsomes and Hepatocytes

(W1230-02-12) Translational PK/PD and First-in-Human Dose Selection of a Monoclonal Antibody Targeting a Membrane Protein

(T1330-02-07) Translational PK/PD Modeling to Predict Human PK and Treg Depletion of a Monoclonal Antibody Based on Preclinical Data

(M1330-02-07) Understanding the Influence of Drug Metabolizing Enzyme Activity on Small Molecule Stability Within a Commonly Used Preclinical Tumor Model

(M1330-02-08) In Vitro Assays for the Evaluation of Innate Immunogenicity in Generic Peptide Drug Products

(T1330-02-08) Machine Learning Approaches for Assessing Medication Transfer to Human Breast Milk: Estimating Milk/Plasma Drug Ratios

(T1330-02-09) Examining PDGFRA Gene Downregulation in the Peripheral Blood of Patients with Functional Dyspepsia

(M1330-02-09) Translational Pharmacokinetic Assessment of Mitragyna Speciosa (kratom), a Potential Treatment Option for Opioid Use Disorder

(M1330-02-10) Development of a Mitra Tip Extraction Assay Coupled with LC-MS/MS for Quantitation of L-Citrulline, L-Arginine, and L-Argininosuccinic Acid: A Novel Approach for Biomarker Analysis

(T1330-02-10) Genetic Polymorphism Based Inhibition on CYP450 by Radix Puerariae lobatae in Healthy Subjects

(T1330-02-11) A PBPK Model for Acetaminophen: Incorporation of SULT Enzyme Ontogeny to Predict Age-Dependent Metabolism and Systemic Exposure in Pediatric Patient Populations

(M1330-02-11) Toxicokinetics of cP12, a Fibronectin-Derived Peptides, in Rats and Dogs Following a Single Intravenous Injection in an Expanded Acute Toxicity Study

(T1330-02-12) A Phase 1, Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-gp Substrate Dabigatran Etexilate in Healthy Subjects

(M1330-02-12) Multi-Strain Sars-Cov-2 Neutralization Assay Qualification

(M1430-02-07) An Overview of Cross-Referencing Approaches to Support Generic Drug Approval

(T1430-02-07) Exploring the Potential Influence of Physicochemical Characteristics on Biodistribution of Iron-Carbohydrate Nanoparticles Using a Chicken Embryo Model

(T1430-02-08) Ontogeny of Drug Metabolizing Enzymes and Its Impact on Valproic Acid Hepatotoxicity: Insights from In Vitro and PBPK Modeling Studies

(M1430-02-08) Transcriptomic Analysis Reveals that Nymphaea odorata Extracts and Fractions Upregulate the Apoptosis, Autophagy, and Unfolded Protein Canonical Pathways in MCF-7 Cells

(M1430-02-09) A PBPK Model for Prediction of Apixaban and Rivaroxaban Secretion into Milk

(T1430-02-09) Evaluation of Methods for Assessing Pre-Dose Steady-State Drug Concentration Attainment in Bioequivalence Studies in Abbreviated New Drug Application (ANDA) Submissions

(T1430-02-10) Modified Dissolution-Permeation Assembly Mimicking In Vivo Condition: An Ideal Method to Test Dissolution Profile of Nanosuspension Formulation

(M1430-02-10) Population Pharmacokinetic Modeling of Time-Varying Effects of Anti-Drug Antibody Formation on the Pharmacokinetics of a Human Monoclonal Antibody in a Rodent Model

(T1430-02-11) Alcohol Dose Dumping in Modified Release Formulations: Critical Considerations for Regulatory Guidance(s)

(M1430-02-11) Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drugs in Various Therapeutic Areas: A Retrospective Survey of BE Study Data Submitted to the FDA

(M1430-02-12) Integrating Omics Data Through AI: Predicting Novel Therapeutic Targets for Therapy-Resistant Cancer Patients

(T1430-02-12) Ocular Pharmacokinetic Model for Intravitreal Antibody Injection

(T1530-02-07) Establishing a Dissolution Safe Space for Ibuprofen as a Model BCS Class IIa Drug Using Product Particle Size Distribution (P-PSD) Approaches to Support Biowaiver Consideration

(M1530-02-07) Evaluation of the Pharmacokinetics and Abuse Potential of Intranasally Administered Extended-Release Oxycodone and Naloxone Abuse-Deterrent Formulations Milled to Different Particle Sizes

(T1530-02-08) Development and Fit-for-Purpose(FFP) Validation of a 35-Color Ex Vivo Stimulation and Activation-Induced Marker (AIM) Assay to Assess Vaccine-Induced Immune Responses in Human Vaccine Trials

(M1530-02-08) PK/PD Modeling for Liver Targeting LNP Formulated tRNA in Transgenic Mice Containing a Premature Termination Codon on the Human Methylmalonyl-CoA Mutase (hMMut)

(M1530-02-09) Dermal PBPK Model for Psoriatic Skin: Clobetasol Propionate Case Study

(M1530-02-10) Predicting Belumosudil Drug-Drug Interactions Using a Physiologically Based Pharmacokinetic Model

(T1530-02-10) Validating Gut-On-A-Chip-Model: Comparison of Caco-2 Transwell and Gut-On-A-Chip Models for Oral Drug Delivery

(M1530-02-11) Circumvention of Targeted Anticancer Drug Resistance by Standardized Yunzhi Extract

(T1530-02-11) Prediction of Lacosamide Concentrations to Optimize Dosing during Pregnancy

(M1530-02-12) Characterizing Interactions of RO7297089, an Anti-B-Cell Maturation Antigen (BCMA)/CD16A Bispecific Tetravalent Antibody with Shed Soluble CD16A Antigen in Plasma In Vitro

(T1530-02-12) Druggability Evaluation of ZEX, a Novel Derivative of Component from Codonopsis Radix