Poster: Methodology - Other topics

Population pharmacokinetic/pharmacodynamic modeling of plasma lyso-sphingomyelin response to enzyme replacement therapy olipudase alfa in patients with acid sphingomyelinase deficiency

Thursday 16 October, 2025

Background: Olipudase alfa (recombinant human acid sphingomyelinase (rhASM)) is an intravenous (IV) enzyme replacement therapy under investigation for the treatment…

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Investigation of the impact of population parameters describing gastric emptying on bioequivalence metrics

Thursday 16 October, 2025

Introduction: Gastric emptying was shown to significantly affect the disposition of losartan (LOS), which is a BCS class I compound…

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Species-specific Expression Databases for Physiologically Based Pharmacokinetic Modeling

Thursday 16 October, 2025

Introduction: During drug discovery and development, understanding and describing the mechanistic drivers of pharmacokinetics (PK) for new molecular entity is…

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nlmixr2, rxode2 and NONMEM: interchangeable models using babelmixr2 and nonmem2rx

Thursday 16 October, 2025

 Introduction: nlmixr2 (www.nlmixr2.org) is an open-source R package, freely available on CRAN[1] and GitHub[2]. It builds on rxode2[3], an R package for…

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Selection of optimal study design based on the bioequivalence simulation study in highly variable drugs

Thursday 16 October, 2025

Objectives: Highly variable drugs (HVD) indicate drugs with within-subject standard deviation (SWR) > 0.294. For HVD, bioequivalence tests are conducted…

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Guiding dose selection of monoclonal antibodies using a new parameter (AFTIR) for characterizing ligand binding systems

Thursday 16 October, 2025

Objectives: In guiding dose selection for monoclonal antibodies, the methods for predicting receptor occupancy (RO) vary in their level of…

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Generation and Application of Avatars (Digital Twins) in Pharmacometric Modelling

Thursday 16 October, 2025

Objectives: The concept of Avatars or Digital Twins is well established in health, engineering, and systems biology. It is the creation…

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Individual Model Averaging to increase robustness in drug effect estimation

Thursday 16 October, 2025

Objectives Non-linear mixed effect models (NLMEM) have been proven to be helpful during drug development to characterize drug effects and…

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Bayesian estimation of parameters in the pharmacokinetic model

Thursday 16 October, 2025

Objectives: The pharmacokinetic (PK) estimation and dose individualization are important to obtain a favorable outcome in a clinical setting. The…

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Simulation of the environmental exposure to fenofibrate nanomaterials based on in vitro- and in silico methods

Thursday 16 October, 2025

Introduction: A rising number of active pharmaceutical ingredients (API) possess physicochemical properties unfavorable for oral absorption [1]. While traditional approaches…

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