Dose Optimization in Drug Development

Description

Arguably the most difficult aspect of drug development, once proof-of-concept is achieved for a novel mechanism, is defining the “right” dose. Indeed, the question rapidly expands to right for whom? An individual? A population? A specific disease? A unique demographic? The answers can yield a dizzying array of alternatives. Yet pressures to rapidly realize the benefits of a new compound often limit time spent in early development (Phase I/II) when such questions have traditionally been explored. To more efficiently address the problem of defining the optimum dose, new approaches are being applied across the disciplines of drug development.The present volume, Dose Optimization in Drug Development, in the series Drugs and the Pharmaceutical Sciences, provides a timely overview of emerging knowledge in this field. This knowledge encompasses techniques for exploring individual as well as population dose optimization including the definition of dose-concentration-response relationships, modeling based on these PK/PD relationships, clinical trial simulations, and application of pharmacogenomic principles. One aspect of this research which should not be lost is the requirement for more highly integrated interactions between the clinicians, kineticists, and statisticians addressing these problems.