Background: Olipudase alfa (recombinant human acid sphingomyelinase (rhASM)) is an intravenous (IV) enzyme replacement therapy under investigation for the treatment…
Read morePoster: Methodology - Other topics
Investigation of the impact of population parameters describing gastric emptying on bioequivalence metrics
Introduction: Gastric emptying was shown to significantly affect the disposition of losartan (LOS), which is a BCS class I compound…
Read moreSpecies-specific Expression Databases for Physiologically Based Pharmacokinetic Modeling
Introduction: During drug discovery and development, understanding and describing the mechanistic drivers of pharmacokinetics (PK) for new molecular entity is…
Read morenlmixr2, rxode2 and NONMEM: interchangeable models using babelmixr2 and nonmem2rx
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…
Read moreSelection of optimal study design based on the bioequivalence simulation study in highly variable drugs
Objectives: Highly variable drugs (HVD) indicate drugs with within-subject standard deviation (SWR) > 0.294. For HVD, bioequivalence tests are conducted…
Read moreGuiding dose selection of monoclonal antibodies using a new parameter (AFTIR) for characterizing ligand binding systems
Objectives: In guiding dose selection for monoclonal antibodies, the methods for predicting receptor occupancy (RO) vary in their level of…
Read moreGeneration and Application of Avatars (Digital Twins) in Pharmacometric Modelling
Objectives: The concept of Avatars or Digital Twins is well established in health, engineering, and systems biology. It is the creation…
Read moreIndividual Model Averaging to increase robustness in drug effect estimation
Objectives Non-linear mixed effect models (NLMEM) have been proven to be helpful during drug development to characterize drug effects and…
Read moreBayesian estimation of parameters in the pharmacokinetic model
Objectives: The pharmacokinetic (PK) estimation and dose individualization are important to obtain a favorable outcome in a clinical setting. The…
Read moreSimulation of the environmental exposure to fenofibrate nanomaterials based on in vitro- and in silico methods
Introduction: A rising number of active pharmaceutical ingredients (API) possess physicochemical properties unfavorable for oral absorption [1]. While traditional approaches…
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