Introduction: Optimal experimental design of population PK/PD studies has received considerable attention in the literature and software development in recent…
Read morePoster: Study Design
PK/PD sampling design optimization following a sustained release formulation of triptorelin using optimal experimental design
Objectives: Sustained release administrations of drugs have improved long-term treatments for the patient. However, the design of clinical trials in…
Read moreEvaluation of designs for biosimilarity crossover trials analysed by nonlinear mixed effects models
Objectives: To assess the similarity between different formulations of a biologic drug, a pharmacokinetic (PK) bioequivalence trial is usually performed…
Read moreFrom Evidence Synthesis to Trial Optimization: The adsim Package for Model-based Simulation in Alzheimer’s Disease
Objectives: Model-based drug development is ideally characterized by both comprehensive synthesis of available evidence as well as realistic simulation of…
Read moreAssessment of expected drug exposure relative maximum safety limits in early phase studies
Introduction: During early phase drug development, such as in single or multiple ascending dose studies, drug exposure should not exceed…
Read moreNew features for population design evaluation and optimisation with R functions: PFIM Interface 3.1 and PFIM 3.2
Objectives: To develop the free R function PFIM [1] for population design evaluation and optimization and to illustrate the use…
Read morePopulation optimal design with correlation using Markov Models
Objectives: Incorporating correlation for continuous data in optimal design has shown to be important [1]. Therefore; different ways of incorporating…
Read moreParallelization in optimal experimental design using PopED
Objectives: Optimal design for population models can be quite time consuming. A natural way to decrease the computer time is…
Read moreThe robustness of global optimal designs
Objectives: A drawback with local optimal designs (OD), e.g. D-optimal, is that the parameters of the model are assumed known….
Read moreComparison of longitudinal data analysis to end of treatment data analysis when evaluating precision in dose-exposure-response in neuropathic pain studies.
Objectives: In neuropathic pain, the primary endpoint for detecting the presence of dose-response has typically been the end of treatment…
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