ABSTRACT
Analytical method development is the process of creating a procedure to enable a new chemical entity of potential therapeutic value to be quantified in a biological matrix. Such methods are required to demonstrate exposure of the test system to the compound for toxicological assessment, and as an aid to understanding its pharmacokinetic and pharmacodynamic behaviour. This chapter outlines the major steps that may be applied in order to establish a new quantitative analytical method and is intended to be read together with other chapters that deal with each of the aspects in more detail.
