Thursday 16 October, 2025
Objectives: A two-stage, adaptive dose-finding, inferentially seamless Phase 2/3 study was designed to optimize the development of dulaglutide (dula), a…
Read morePoster: Study Design
Influence of study design and associated shrinkage on power of the tests used for covariate detection in population pharmacokinetics
Thursday 16 October, 2025
Objectives: In 2009, Savic et al [1] showed that high shrinkage caused by poorly informative study designs can hide or…
Read moreOptimal Experimental Design for receptor drug development with PET studies
Thursday 16 October, 2025
Objectives:To increase the efficiency of pharmacokinetic/pharmacodynamic experiments, optimal experimental design has been used to successfully optimize dose allocation and sampling…
Read moreStrategic comparator modeling and simulation to optimize dose selection for a dose-range finding study
Thursday 16 October, 2025
Objectives: Drug X is under development using a rapid straight-to-IIB development paradigm. To support dose selection for this dose-range-finding study,…
Read moreClinical Trial Design Optimization: A Pharmacokinetic Sampling Plan for a Phase 3 Clinical Trial in Mild Alzheimer Disease Patients
Thursday 16 October, 2025
Introduction: One aspect of design optimization concerns finding an efficient pharmacokinetic (PK) sampling schedule to properly characterize PK of a…
Read moreFIM approximation, spreading of optimal sampling times and their effect on parameter bias and precision.
Thursday 16 October, 2025
Objectives: Optimizing potentially different designs for multiple individuals with the first order (FO) linearized Fisher Information Matrix (FIM) will produce…
Read moreDetermination of antisense oligonucleotide tissue half-life
Thursday 16 October, 2025
Objectives: To estimate the tissue half-life of an antisense oligonucleotide (ASO) accurately and precisely, by properly designing and analysing a…
Read moreThe feasibility of model-based exposure calculations in preclinical toxicology
Thursday 16 October, 2025
Objectives: An important part of drug development involves the establishment of safe exposure levels in humans. Preclinical experiments often use…
Read moreModel-based meta-analysis of summary clinical outcome data in idiopathic pulmonary fibrosis (IPF)
Thursday 16 October, 2025
Objectives: (1) To perform a model-based meta-analysis of comparative effectiveness of various drugs investigated in treating IPF patients, and to…
Read moreOptimal design of in vitro time kill curve experiments for the evaluation of antibiotic effects.
Thursday 16 October, 2025
Objectives: In order to integrate information of antibiotic effects from in vitro time kill curve experiments semi-mechanistic pharmacokinetic-pharmacodynamic (PKPD) models…
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