<1032> Design and Development of Biological Assays

BRIEFING 1 2 <1032> Design and Development of Biological Assays. This General Chapter 3 Design and Development of Bioassays <1032> is one of an integrated group of new 4 General Chapters that provide guidance across several complementary bioassay topics. 5 The others include Biological Assay Validation <1033>; Analysis of Biological Assay 6 <1034>; and an as-yet unnumbered " roadmap " chapter that will include a glossary 7 applicable to General Chapters <1032>–<1034>. The group arose from one source, 8 General Chapter Design and Analysis of Biological Assays <111>, that is now official in 9 the US Pharmacopeia (USP). The partitioning of chapters to different aspects of 10 biological assays allows both greater focus and clarity and the opportunity to expand on 11 issues. As the group of General Chapters evolves, General Chapter <111> will remain 12 in modified form. Thus the entire group when completed will consist of five USP General 13 Chapters. 14 15 The Bioassay Development ad hoc Advisory Panel of the Statistics Expert Committee 16 encourages input from all interested parties regarding the proposed <1032>. USP's 17 intent is to reflect the best contemporary practices regarding the design and 18 development of bioassays. This will be achieved when members of the bioassay 19 community take advantage of this opportunity to engage in <1032>'s development by 20 responding to this In-Process Revision. Comments regarding <1032> should be sent to 21 Tina S. Morris, PhD ([email protected]). 24 25 1. INTRODUCTION 26 27 1.1 Purpose 28 29 General Chapter Design and Development of Biological Assays <1032> presents 30 methodology for the development of bioassay procedures that have sound experimental 31 design, that provide data that can be analyzed using well-founded statistical principles, 32 and that are fit for their specific use. 33 34 General Chapter <1032> is one of a group of five planned General Chapters that focus 35 on relative potency assays, in which the activity of a Test material is quantified by 36 comparison to the activity of a Standard material. However, many of the principles can 37 be applied to other assay systems. 38 39 This General Chapter is intended to guide the design and development of a bioassay for 40 a drug product intended for commercial distribution. Although adoption of this chapter's 41 recommended methods may be resource intensive during initial drug development, 42 early implementation may yield benefits. 43 44 1.2 Audience 45 46