This talk addresses key preclinical and early translational challenges in oncology model-informed drug development. It explores emerging immunomodulatory therapies,alongside the…
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Opemalirsen antisense oligonucleotide targeting the APOL1 mRNA provide dose-dependent APOL1 reduction in plasma
Objectives APOL1-mediated kidney disease (AMKD) is associated with toxic gain of function variants in people of African ancestry with the…
Read moreDEVELOPMENT OF AN INTERSPECIES-SCALED PBPK MODEL AND STRUCTURAL PK–PD FRAMEWORK FOR ABROCITINIB
Introduction / Objective Abrocitinib is an oral selective Janus kinase 1 (JAK1) inhibitor approved for the treatment of moderate-to-severe atopic…
Read moreOpemalirsen antisense oligonucleotide targeting the APOL1 mRNA does not prolong the QTc interval.
Objectives Opemalirsen (previously known as AZD2373) is an antisense oligonucleotide (ASO) targeting the APOL1 mRNA. It is currently explored as…
Read moreQuantitative Predictive Check (QPC): A Scalar Framework for Objective and Optimization-Ready VPC Evaluation
Introduction: Model evaluation in pharmacometrics relies on multiple criteria, including likelihood-based statistics, parameter precision, plausibility of covariate effects, and graphical…
Read moreApplication of a Simulation-Based Diagnostics for Survival Evaluation in Joint Models
Introduction: Joint modeling methodology that integrates longitudinal biomarkers and time-to-event outcomes has become an essential component of pharmacometric analyses in…
Read moreINTEGRATED POPULATION PHARMACOKINETIC AND EXPOSURE-RESPONSE MODELING OF ENLICITIDE IN HYPERCHOLESTEROLEMIA PATIENTS SUPPORTS CLINICAL DOSE RECOMMENDATION ACROSS PATIENT SUBGROUPS
Introduction: Despite the well-established cardiovascular benefit of LDL-cholesterol (LDL-C) lowering, real-world use of PCSK9-targeted therapies remains limited, in part due…
Read moreModel-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact
Title: Model-Informed Drug Development at Sِaudi FDA: Approaches, Applications, and Regulatory Impact Author: Alanood Alkhaldi (1), Jamilah Alnahdi(1), Abdullah Alsultan(2),…
Read moreIs regrowth of Mycobacterium tuberculosis always a sign of phenotypical resistance? A model-based approach to interpret drug instability and the implications for potency estimation in time-kill assays.
Introduction:The observed regrowth of Mycobacterium tuberculosis (Mtb) in vitro is often attributed to the emergence of phenotypical resistance or relapse-associated…
Read moreMachine learning for covariate imputation – application in a real-world scenario
Objective: Population pharmacokinetic (PopPK) models describe the changes in drug concentration across diverse patient populations, leveraging covariate effects using a…
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