BRIEFING

 〈1030〉 Biological Assay Chapters—Overview and Glossary. This proposal is based on the version of the chapter official as of December 1, 2013. The Statistics Expert Committee proposes to update and expand the scope of the current chapter by changing the title to “An Introduction to the Biological Assay Chapters—Overview and Glossary” and adding the following new sections:

• Introduction to Biological Assays

• Some Important Characteristics of Bioassays

• Life Cycle Concepts and Framework for the Bioassay Chapters

• Categories and Levels of Variability Throughout the Bioassay Life Cycle

• Brief Description of the Bioassay Chapters

• Bioassay Glossary

 This major revision will assist bioassay professionals in starting with the more technical chapters Design and Development of Biological Assays 〈1032〉, Biological Assay Validation 〈1033〉, and Analysis of Biological Assays 〈1034〉.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GC-STAT: R. Dasari)

 Correspondence Number—C315026