USP〈1032〉 DESIGN AND DEVELOPMENT OF BIOLOGICAL ASSAYS

1. INTRODUCTION

1.1 Purpose and Scope

General chapter Design and Development of Biological Assays 〈1032〉 presents methodology for the development of bioassay procedures that have sound experimental design, that provide data that can be analyzed using well-founded statistical principles, and that are fit for their specific use.

General chapter 〈1032〉 is one of a group of five general chapters that focus on relative potency assays, in which the activity of a Test material is quantified by comparison to the activity of a Standard material. However, many of the principles can be applied to other assay systems.

This general chapter is intended to guide the design and development of a bioassay for a drug substance or product intended for commercial distribution. Although adoption of this chapter's recommended methods may be resource intensive during assay development, early implementation can yield benefits. Lastly, the perspectives and methods described herein are those recommended from among the many alternatives which contemporary bioassay theory and practice offers.

Focus on Relative Potency

Because of the inherent variability in biological test systems (including that from animals, cells, instruments, reagents, and day-to-day and between-lab), an absolute measure of potency is more variable than a measure of activity relative to a Standard. This has led to the adoption of the relative potency methodology. Assuming that the Standard and Test materials are biologically similar, statistical similarity (a consequence of the Test and Standard similarity) should be present, and the Test sample can be expected to behave like a concentration or dilution of the Standard. Relative potency is a unitless measure obtained from a comparison of the dose-response relationships of Test and Standard drug preparations. For the purpose of the relative comparison of Test to Standard, the potency of the Standard is usually assigned a value of 1 (or 100%). The Standard can be a material established as such by a national (e.g., USP) or international (e.g., WHO) organization, or it could be an internal Standard.

Source from USP and Please refer to USP for details:

https://online.uspnf.com/uspnf/document/1_GUID-5005D5F9-7475-4169-9E10-A13AAD3189D8_1_en-US

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