ABSTRACT
This chapter focuses on Bayesian approaches for both analytical method validation and transfer. Analytical methods are broadly used across all aspects of drug research and development to quantify risk and aid decision-making. During clinical development of the lead drug, analytical tests are performed to qualify clinical trial materials, evaluate clinical performance, and determine optimal dosing regimens. Analytical methods play an important role in assessing the quality, safety, and efficacy of a drug product throughout its lifecycle. Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy, sensitivity, specificity, and reproducibility and are suitable for their intended purpose. A systematic approach for using Design of experiments for analytical method development and validation is discussed by R. J. Little. The plan includes a written document describing the method transfer plan, acceptance criteria, personnel training at the receiving laboratory, implementation of validation/transfer experiments, and statistical analysis.
