Validation in Proteomics and Regulatory Affairs

Experimental design principles for achieving validity and efficiency are required for any multi-variable experiment. In this chapter we attempt to review validation principles applicable to complex high-throughput experiments such as proteomic profiling. Typical proteomic study consists of a string of multiple steps each of which can be validated by different orthogonal methods. Nevertheless, all steps will have an impact on the overall outcome, providing answers of biological importance. As much as validation of analytical methods is quite well established, validation of experimental design or bioinformatics analysis is still in its infancy. We also discuss the validation of proteomic profiling experiments from the perspective of regulatory affairs.