ABSTRACT
In biopharmaceutical process development, data are often collected to address specific questions: (1) Is the bioassay used to measure the drug activity fit for its intended purpose? (2) Does the newly received batch of raw materials meet acceptance criteria? (3) Is the manufacture process in the state of control? To effectively and adequately answer these questions, it is essential to use statistical tools for data collection, analysis, and interpretation. In this chapter, we introduce statistical concepts, principles, and methods fundamental to bioprocess development. We also discuss good statistical practices (GSP) in the analysis and interpretation of analytical data.
