Method selection, development, and optimization

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 revisits examples of how sample preparation is further addressed, refined, and knowledge amassed through the risk assessment and indeed evaluation stages of the holistic method. The first step after definition of the analytical target profile is to select the most appropriate analytical measurement technique. Following the selection of a suitable analytical measurement technique, the next step is to ensure that the sampling strategy is appropriate in order to fulfill the purposes of the measurement method. Once draft method conditions have been selected and tested to ensure they work as predicted, the next step in the process is to evaluate the method in more detail with the goal of enhancing method understanding and robustness.