Method Design and Understanding

During drug development phases, analytical methods can change considerably and so method selection, development, and optimization activities are not a one-time activity but an ongoing process. This chapter describes a functional approach designed for enhancing analytical efficiency that structures method selection, development and optimization processes, and uses real-life pharmaceutical case studies. It focuses on question: which analytical measurement technique is capable of delivering data compliant with both the analytical target profile (ATP) and practical business requirements. Once the method operable design region (MODR) has been defined the remaining stages of the method optimization process involve defining the control strategy for the method. The control strategy involves a number of elements, which are outlined in the chapter. Analytical methods that are developed in the pharmaceutical industry must accurately quantify analytes with acceptable accuracy and precision while at the same time, be robust and easily transferable to the quality control or research laboratory.