ABSTRACT
Identifiability analysis can be an important step in the development of any experimental design, and it should not be overlooked, especially when working with new and involved models. A pilot study gives the investigator the opportunity to understand the dosing and sampling arrangements, to see the analytical method in action, and to obtain preliminary information about the drug disposition and pharmacological responses including potential undesirable effects. A well designed and executed pilot study should always precede the planning of the main study as it will provide much useful information about the dosing, sampling, and subsequent analyses of drug concentrations and results. Samples collected during a controlled infusion will generally provide as much pharmacokinetic information as samples collected shortly after an intravenous bolus. The Laplace transform method is easier to use than the Taylor series method, but it is not applicable to nonlinear or time variant systems.
