1. INTRODUCTION

The intended scope of this chapter includes guidance for the analysis of results of bioassays described in the 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 Design and Development of Biological Assays 〈1032〉 and Biological Assay Validation 〈1033〉, respectively, and all three chapters are supported by An Introduction to the Biological Assay Chapters—Overview and Glossary 〈1030〉. Definitions of terms used in this chapter may be found in 〈1030〉, Bioassay Glossary.