Poster: Methodology - Study Design

Model-based experimental design recommendations for in vivo studies of the novel anti-tuberculosis drug MPL-447 improve characterization of PK and PD

Thursday 16 October, 2025

Introduction: The novel mycobacterial membrane protein large 3 (MmpL3) transporter inhibitor MPL-447 is being developed for tuberculosis (TB) treatment by…

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Design evaluation and optimisation in nonlinear mixed effects models with the R package PFIM

Thursday 16 October, 2025

Objectives: Nonlinear mixed effects models (NLMEMs) are widely used in model-based drug development to analyse longitudinal data. For optimising the…

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Design evaluation and optimisation in nonlinear mixed effects models with the R package PFIM 6.0

Thursday 16 October, 2025

Objectives: Nonlinear mixed effects models (NLMEMs) are widely used in model-based drug development to analyse longitudinal data. For optimising the…

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Simulation-based evaluation of combined Likelihood Ratio Test (cLRT) and Multiple Comparison Procedure (MCP) approaches to identify a dose-response relationship in the oncology setting under different study design variables

Thursday 16 October, 2025

Background In oncology, the FDA requests for more rational derivation of optimal doses [1]. A first step to dose optimisation…

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Simulating maximum tolerated dose-finding oncology trials using the InSilicoTrials cloud-based platform

Thursday 16 October, 2025

Introduction: In silico clinical trials are expected to play an increasingly important role in guiding the design of oncology phase I…

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Prediction of human pharmacokinetics of subcutaneously administered depot formulation using MBPK model

Thursday 16 October, 2025

Introduction: Subcutaneous depot formulations are increasingly being utilized, especially for the administration of biopharmaceuticals. However, the mechanism of drug release…

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Creation of Pharmacometric Framework to Evaluate Clinical Trial Data on Predictive Biomarkers

Thursday 16 October, 2025

Objectives:  The identification of biomarkers that can predict subjects to respond to a therapy is an important objective of what…

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Evaluation of release techniques for nanocarriers on the basis of IVIVC-PBPK modeling

Thursday 16 October, 2025

Introduction: The drug release kinetics is one of the significant factors influencing the efficacy of nanocarriers. Often the in vitro…

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How to reduce the total number of samples in a bioequivalence study without impacting statistical power

Thursday 16 October, 2025

Introduction/Objectives: Bioequivalence (BE) or biosimilarity studies are typically conducted to compare two drugs or formulations and show their similarity [1,…

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Tapping into the potential of pharmacometrics in preclinical infection models: a low-hanging fruit or joined efforts needed?

Thursday 16 October, 2025

Introduction: In the development of alternative anti-infective combination therapies, preclinical in vivo infection studies are performed to characterise the PKPD…

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