BRIEFING

 〈1032〉 Design and Development of Biological Assays. This proposal is based on the version of the chapter official prior to 2013. This revision includes changes based on feedback from stakeholders, better coordination with other USP bioassay chapters, and practical examples. Bioassay performance requirements are developed in life cycle terms. The reasons and methods for setting similarity equivalence bounds based on the impact (on log potency) are more fully developed and more strongly recommended. There is additional emphasis on using design and analysis strategies to control bias of potency and improve monitoring capabilities. The discussion of outliers, including references to Analytical Data—Interpretation and Treatment 〈1010〉, is expanded. This revision contains more explanation of and examples about groups (structure design), mixed models, and alternative parameterization, less support for weighted models, and more discussion about strategic choices and the links between practical constraints and their statistical implications.

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

 (GCSTAT: H. Tu)

 Case ID—SUB-783