Leveraging pharmacometrics in early phase anti-inflamatory drug development

Abstract

The application of pharmacometrics to knowledge acquisition adds value to the drug development process because it enables the translation of information about drug action and interaction with the disease process into knowledge by enabling quantitative descriptions of drug actions, and the leveraging of this knowledge across different stages of drug development. This chapter describes a pharmacometrics based strategy of evolving a drug candidate from the nonclinical phase of drug development to the early phase of clinical drug development using an anti-inflammatory drug candidate as an example. Modeling was used to extract knowledge from nonclinical data and used to simulate a first time-in-human study. The results of the simulation study formed the basis for recommending a range of doses for a single dose escalation study, which were later compared with the results of the simulation study to determine the usefulness of the approach. © American Association of Pharmaceutical Scientists 2011.