Objectives: Effects of antibiotics on bacterial growth are typically modeled by a direct change of growth or death rate of a…
Read morePoster: Methodology - New Modelling Approaches
An exposure-response model relating nicotine plasma concentration to momentary craving across different nicotine replacement therapy formulations
Objectives: Tobacco use is estimated to cause over 7 million avoidable deaths yearly [1] by increasing the risk of developing…
Read moreContribution of nonlinear mixed effects models and penalised regression approaches in pharmacogenetic population studies
Context: Pharmacogenetics is now part of many clinical trials, in particular in population pharmacokinetic/pharmacodynamic (PK/PD) studies. Several methods are available…
Read moreUse of mixture models in pharmacometric model-based analysis of confirmatory trials: part I – simulation study evaluating type I error and power of proof-of-concept trials
Objectives: Proof-of-concept studies (POC) are designed to eliminate inefficient drugs. Statistics underlying such decision are critical. Pharmacometric approaches based on…
Read morePK Precision Estimation to support the Design of a Pediatric Study of Belimumab Administered Subcutaneously
Objectives: Belimumab (BENLYSTA) is a monoclonal antibody that binds to the B-lymphocyte stimulator protein and is currently approved for the…
Read moreSBPOP/mPD: Informing dose-concentration-response relationships – Application to study design and information generation based on competitor data
Objectives: The main goal of quantitative approaches to drug development is the integration of all available information in order to…
Read moreExploring simplification of a target-mediated drug disposition (TMDD) model for bispecific antibodies for potential application to data-driven modelling
Introduction: Bispecific antibodies are antibodies with two binding sites, directed against two different antigens or two different epitopes on the…
Read moreAn Industry Perspective on Extrapolation in Pediatric Drug Development: A Quantitative Approach to Assess Similarity of Adult and Pediatric Efficacy.
Objectives: Recruitment of patients into pediatric studies is difficult and slow, and traditional fully powered pivotal trials are prohibitive. For…
Read moreDistributed transit compartments for arbitrary lifespan distributions in aging populations
Objectives: In an aging population every individual has its own and unique lifespan, and after expiration the individual has to…
Read moreDevelopment and implementation of drug-drug interaction mechanisms with target-mediated drug disposition
Objectives: We extend competitive, uncompetitive and non-competitive drug-drug interaction (DDI) mechanisms with target-mediated drug disposition (TMDD). We investigate quasi-equilibrium (QE)…
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