Methods to Determine Optimal Sampling Windows for Nonlinear Mixed Effects Models

Background: D-optimality is often used to design an optimum experiment for population pharmacokinetic (PK) studies. However, obtaining samples at specific time points is not always feasible due to logistic constraints. Therefore many D-optimal designs may be executed sub-optimally and risk attaining uninformative data. Sampling windows (a time range around each of the D-optimal time points) can […]

Adaptive Bridging Studies in Pharmacokinetics

Background: Bridging study is a concept for extrapolating information gathered from clinical study in an original region, e.g. an adult patient population, to a new region, e.g. a paediatric patient population. Such studies generally include additional pharmacokinetic information to provide knowledge of the time course of exposure in the new region. Since systematic differences are possible […]

Robust D-optimal Design of Nonlinear Fixed Effects Pharmacokinetic Model

Background: D-optimality is often used to design an optimum experiment for the purpose of parameter estimation. When the model is nonlinear, D-optimal designs depend on the nominal parameter values in the model, which are unknown. In order to address this dependency issue, various robust optimal design methods have been introduced [1, 2]. These methods utilize prior […]