Drug development is a sequential process with the aims of establishing efficacy and characterising the dose-regimen vs response relationship. Early…
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Pharmacogenetics
The reasons for inter-subject variability in dose response can reside within the pharmacokinetic (PK) or the pharmacodynamic phase (PD) of…
Read more42 Bayesian Individualization via Sampling-Based Methods.
In this talk I will consider the situation where we wish to adjust the dosage regimen of a patient based…
Read moreOptimization of a ”First Dose in Man” Study using a NONMEM Model for Mammals
”First dose in man” – studies should always be designed on the basis of preclinical data. Allometric scaling is often…
Read moreNon-parametric methods for continuous and binary variables in population PK/PD.
Non-parametric methods have been proposed in pharmacokinetic/pharmacodynamic population modelling; these methods aim at estimating population characteristics without imposing unnecessary structure…
Read moreAn Industrial Perspective: Practical Stages in Model Development
There are differences in the implementation of the population approach in industry when compared to the population approach in an…
Read moreRelationship Between the Pharmacokinetics and the Pharmacodynamics of Taxotere (RP56976, DOCETAXEL) in Cancer Patients
A sparse pharmacokinetic sampling strategy was implemented during the first cycle of docetaxel treatment in 24 Phase II studies to…
Read moreDiscrimination between Rival Dosing Histories
Obtaining an adequate dosing history for population PK modelling is associated with considerable problems. Essentially three types of dosing histories…
Read moreDetermination of Relative Potency for Drug and Metabolite in Vivo
One of the tasks in drug development is to assess what molecular species are contributing to the effect and toxicity…
Read morePopulation Kinetics and Individual Drug Dosage Adjustment
In clinical practice, drug dosage adjustment is confronted with three main obstacles: first only sparse individual data is available, secondly…
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