USP〈1034〉 ANALYSIS OF BIOLOGICAL ASSAYS

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〉.

This chapter presumes that decisions about the design and analysis strategy are made based on evidence about the properties of the assay method and design gained during development, checked during validation, which will then be monitored and reviewed periodically throughout the remainder of the life of the bioassay system and revised when appropriate. Chapter 〈1030〉 addresses the life cycle of a bioassay generally. The early steps in this process are covered in chapter 〈1032〉, while validation is covered in chapter 〈1033〉.

Topics addressed in 〈1034〉 include statistical concepts and methods of analysis for the calculation of potency and confidence intervals for a variety of relative potency bioassays, including those referenced in USP. Most of 〈1034〉 is intended for use by those who do not have extensive training or experience in statistics and by statisticians who are not experienced in the analysis of bioassays. Sections that are primarily conceptual require only minimal statistics background. Most of the chapter and all of the methods sections require that the nonstatistician be comfortable with basic statistical concepts (as in Analytical Data—Interpretation and Treatment 〈1010〉) and with linear regression. Section 2. Overview of Analysis of Bioassay Data introduces the basic steps for analysis of a bioassay. Section 3. Essentials of Models’ Functional Forms presents various model choices and corresponding methods of analysis. Section 3. Essentials of Models’ Functional Forms presumes a simple design (e.g., in a plate-based bioassay, a design where combinations of sample and concentration are randomized throughout the plate) so that the basics of the models and analyses can be presented without the complication of design effects. Section 4. Confidence Intervals and Combining Results covers confidence intervals and combining results from multiple runs (executions of the assay method). Section 5. Additional Details and Advanced Topics, introduces selected complex methods, and thus requires a more extensive statistics background. Section 5. Additional Details and Advanced Topics is intended primarily for statisticians.

Approaches in this chapter are recommended, recognizing the possibility that alternative statistical methodologies may be employed. Additionally, the information in 〈1034〉 is presented assuming that computers and suitable software will be used for data analysis. Consideration of these recommendations should be part of the normal process of designing and developing a reliable bioassay.

Source from USP:https://online.uspnf.com/uspnf/document/2_GUID-CC133EE7-6ACF-4565-8740-AE4EECF3AF58_20101_en-US?source=Search%20Results&highlight=1034

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