INTRODUCTION Successful treatment of uncomplicated malaria relies on oral therapies, yet the absorption of antimalarial agents such as artesunate remains…
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Treating models as data: advancing model-based meta-analysis through aggregate data modelling
Objectives Pharmacometric or population modelling traditionally relies on individual level data. Increasingly, previously published models and summary data are recognized…
Read moreM-PROTEIN DYNAMIC METRICS TO SUPPORT EARLY DRUG DEVELOPMENT DECISIONS IN MULTIPLE MYELOMA
Objectives Model-derived tumor dynamic metrics have shown promise in predicting overall survival (OS) [1,2,3] to support late-stage drug development (DD)….
Read morePreclinical and clinical pharmacokinetic prediction via Machine Learning
Objectives Reliably assessing pharmacokinetics (PK) as early as possible in the R&D pipeline can potentially reduce animal studies, accelerate timelines…
Read moreLimited pharmacokinetic and pharmacodynamic modelling research of lymphodepleting agents in CAR-T cell therapy: a literature review
Introduction/objectives: Chimeric antigen receptor (CAR) T-cell therapy is an immunotherapy that has transformed the treatment of haematological malignancies by enabling…
Read moreThe Empirical Bayes Variational Autoencoder – A Neural ODE Approach for Population Modeling in Pharmacology
Objectives Population modeling using nonlinear mixed-effects (NLME) frameworks is fundamental to pharmacometrics, enabling rigorous quantification of inter- and intra-individual variability…
Read moreModeling the Effect of Long-Acting Injectables of DAA Therapy to Reach Hepatitis C Elimination among People Who Inject Drugs
Introduction: Worldwide >50 million individuals are estimated to be chronically infected with hepatitis C virus (HCV), with ~1.0 million new…
Read morePhysiologically-based pharmacokinetic modeling to predict human toxicokinetics of the synthetic cannabinoid 5F-Cumyl-P7AICA and its major metabolite: from pig to human translation
Introduction: New psychoactive substances (NPSs) have attracted significant attention from public health authorities due to their growing use as alternatives…
Read moreModel-based meta-analysis (MBMA) of effect of biologics on FEV1 in severe asthma
Objectives: Asthma patients exhibit significant heterogeneity in disease presentation driven by involvement of type I (allergic) and type II (eosinophilic)…
Read moreMODEL-INFORMED APPROACHES FOR PEDIATRIC TYPE 2 DIABETES EVIDENCE GENERATION: INSIGHTS FROM A MODEL-BASED LONGITUDINAL HBA1C META-ANALYSIS FROM EMA MARKETING AUTHORIZATION APPLICATIONS
Introduction: The efficacy of a new medicinal drug product indicated for the treatment or prevention of Type 2 Diabetes Mellitus…
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