This course will be held on November 16, 2015 in Baltimore, MD, as part of CHI's Immunogenicity and Bioassay Summit 2015. COURSE DETAILS: Instructor: Liming ShiLiming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company This course will focus on the fundamentals of statistics and simple methodology that are routinely applied in bioassay laboratories. Covered topics will include review of statistical concepts and calculations, study design, assessing bioassay measurement quality and comparative studies. The following topics will be covered: •Uniqueness of bioassay, especially cell-based potency assay •Considerations in bioassay development and validation •Bioassay measurements and calculations •Quality control of bioassay performance •Comparative studies for bioassay development and transfer