Chapter 6.2 Use of microdialysis in drug discovery and development: industry and regulatory perspectives

Abstract

Abstract This chapter discusses the role of microdialysis in the discovery and development of drugs that act on the central nervous system (CNS). The focus is on strategies that will help to select high-quality compounds for development and that contribute to reducing the current high attrition rate in the pharmaceutical industry. Pharmacodynamic and pharmacokinetic microdialysis applications are discussed to illustrate how and when microdialysis can be used in the different stages of the discovery and development process. Since microdialysis data are likely to become an important part of new drug submissions, and thus may potentially contribute to the FDA Critical Path Initiative to facilitate innovation in drug development, some regulatory aspects will be discussed as well.