Objectives Opemalirsen (previously known as AZD2373) is an antisense oligonucleotide (ASO) targeting the APOL1 mRNA. It is currently explored as…
Read morePoster: Drug/Disease Modelling - Safety
Pharmacometric Evaluation of Patient-Reported Symptom Burden in Oral Anticancer Therapy With Axitinib and Cabozantinib Using Minimal Continuous-time Markov Models
Objective: Adverse drug events (ADEs) are a substantial burden for patients undergoing antitumor therapy and, in the worst case, may…
Read moreHandling Hysteresis in Concentration–QTc Analysis: A PK/PD Effect-Compartment Approach Illustrated with Vanoxerine
Introduction: The assessment of proarrhythmic risk via the analysis of QT interval prolongation is an integral part of drug development. Since…
Read moreA framework for drug safety assessment based on target affinity, drug exposure and plasma protein binding – dissecting FDA drug-induced cardiotoxicity data from a translational pharmacology perspective
Introduction: Cardiac safety assessment is an integrated part of drug discovery and development. Drug candidates with risk of adversely affecting…
Read moreModel-based assessment of the prothrombin time test during transition from rivaroxaban to warfarin
Objectives For patients receiving long-term anticoagulant therapy, various clinical situations may arise in which it is necessary to transition from…
Read moreOptimizing Cyclosporine A Therapy in Pregnancy: A Maternal-Fetal Physiologically-Based Pharmacokinetic Modeling Approach
Introduction: Cyclosporine A (CsA) is increasingly being used in reproductive medicine and pregnancy immunotherapy. However, pregnancy-induced physiological changes may substantially…
Read moreComparative Acute Kidney Injury Risk Across Antibiotics Commonly Used for Severe Infections in Hospitalized Patients: A Time-Varying Causal Analysis
Introduction / Objectives Antibiotics are among the most frequently prescribed medications in hospitalized patients, and several agents have been associated…
Read moreSafety Analysis of SAB-142, a Fully Human Anti-Thymocyte Globulin, Demonstrates Immunomodulatory Effects on Lymphocytes
Objectives Rabbit and horse-derived anti-thymocyte globulin (rATG or hoATG) are established drugs for immunosuppression that are administered following organ transplantation….
Read moreMODEL-INFORMED COMPARATIVE PHARMACOKINETIC AND PHARMACOLOGIC PROFILING HIGHLIGHT JAK1 SELECTIVITY OF POVORCITINIB
Objectives: Povorcitinib (INCB054707) is a novel, orally administered, highly selective Janus kinase (JAK)1 inhibitor currently in phase 3 clinical trials…
Read morePREDICTION OF DRUG-DRUG INTERACTIONS BETWEEN AYAHUASCA ALKALOIDS AND SSRIS USING PBPK MODELING WITH EXPLORATORY ANALYSIS OF CYP2D6 POLYMORPHISMS
Introduction: Ayahuasca is a psychedelic preparation containing N,N-dimethyltryptamine (DMT) and β-carbolines, such as harmine (HRM), a reversible monoamine oxidase A…
Read more