Analytical methods provide critical data in support of the understanding and control of pharmaceutical materials. As such, methods should be designed with the intent and performance well defined (e.g., purpose, specificity, sensitivity, cycle time, accuracy, precision) and over engineered to ensure conformance. Throughout the years, many approaches to methods development have been successfully applied, although modern methods development schemes utilize systematic method screens and software optimization to help define and refine the final set point conditions.

The outcome of contemporary pharmaceutical methods development is the design of a quality method centered within a well characterized and understood robust region that consistently delivers the intended performance. The knowledge obtained during method development, optimization and performance verification help to understand both the region over which the analytical method will perform acceptably as well as the identification of method factors to be controlled for ensured acceptable method performance. As a result of contemporary pharmaceutical methods development, enhanced method understanding and robustness will result in fewer method failures over the lifecycle of the method.

This presentation will discuss contemporary pharmaceutical methods development concepts and workflows, with emphasis on the steps subsequent to the identification of the initial method conditions, including, risk assessments, experimental designs to characterize and understand method performance, and computational approaches to better understand method robustness and to select the method’s set point conditions.