Objectives: Optimal design (OD) theory as a tool to increase the efficiency of clinical studies, though theoretically well-established, still suffers from…
Read moreOral: Other Topics
Limited sampling strategy for a population pharmacokinetic modelling of cocktail of phenotyping drugs
Objectives: Cocktail approach using a combination of probes to phenotype several cytochromes P450 and transporters, is of high interest in…
Read moreCoupling complex mechanistic PK/PD modelling with dynamic system analysis to obtain relevant clinical/biological insights. Application to gonadotropin hormone release agonist
Objectives:The gonadotropin hormone release agonist triptorelin (TPT) administered subcutaneously or intramuscularly in sustained release (SR) formulations is being used in…
Read moreA model of glucose clearance to improve the description of glucose homeostasis
Objectives: Glucose homeostasis models have been developed as tools for the clinical development of glucose-lowering drugs [1]. The description of the…
Read morePanel Discussion: Modelling and Simulation and the Regulatory Process
This discussion will recapture a recent workshop at the EMA (December 2011) and promote a future collaboration between modellers working…
Read moreProposal for a Web-Based Open Pharmacometrics Curriculum
Objectives: Given the small number of formal academic training programs and associated faculty, resource sharing and collaboration in pharmacometrics (PM) training…
Read moreThe Role of Model Based Drug Development – Is it time to repaint the canvas?
Drug development and regulatory decisions are driven by information that is compiled primarily from clinical trials and other supportive experiments,…
Read moreApplication relevant shrinkage metrics
Background: There is a general concern that high η-shrinkage [1] may bias applications such as sequential PKPD analysis and sub-group…
Read moreConsiderations when deriving time-averaged exposure for censored subjects for logistic regression exposure-response analyses
Objectives: Exposure-response (ER) analyses are routinely performed as part of model-informed drug development to evaluate the risk-to-benefit ratio for dose…
Read moreScaling pharmacokinetics to estimate the “first dose in children”: comparing allometric scaling and PBPK
Introduction: For the estimation of “first dose in children” scaling of the pharmacokinetics (PK) from adults to children is required. Two…
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