1. INTRODUCTION

Although advances in chemical characterization have reduced the reliance on bioassays for many products, bioassays are still essential for the determination of potency and the assurance of activity of many proteins, vaccines, complex mixtures, and products for cell and gene therapy, as well as for their role in monitoring the stability of biological products. The intended scope of general chapter Analysis of Biological Assays 〈1034〉 includes guidance for the analysis of results both of bioassays described in the United States Pharmacopeia (USP), and of non-USP bioassays that seek to conform to the qualities of bioassay analysis recommended by USP. Note the emphasis on analysis—design and validation are addressed in complementary chapters (Development and Design of Bioassays 〈1032〉 and Biological Assay Validation 〈1033〉, respectively).