A new General Chapter <1032> to address the design of biological assays is also being proposed. The revision to USP's existing Chapter <1033> on the validation of biological assays reflects the comments received on an original proposal to revise the chapter released in March 2009. Abstract. Biological assays (bioassays) are procedures to estimate the potency of a substance by studying its effects on living organisms, tissues, and cells.Bioassays are essential tools for gaining insight into biologic systems and processes including, for example, the development of new drugs and monitoring environmental pollutants. USP <1033>, Biological Assay Validation, 2009. 5. Limit of Detection and Limit of Quantitation, Clinical Biochem Review, August 2008. All figures are courtesy of the author. "Method Validation Essentials, Limit of Blank, Limit of Detection, and Limit of Quantitation," BioPharm DSC USP-NF General Chapters25 USP-NF General Chapters This section contains selected official general chapters that are reprinted from the USP.Only those USP chapters considered relevant for the analysis and/or manufacturing of dietary supplements are included in this section. Distinguishing properties Bioassay guidelines Originally USP <111> and EP 5.3 <111> was split into two chapters, USP <1032> Design and Development of Biological Assays and USP <1034> Analysis of Biological Assays <1033> Biological Assay Validation added to the suite "Roadmap" chapter (to include glossary) * Bioassay guidelines (cont.) Page 1 of 25 Commentary - First Supplement to USP 35-NF 30 In accordance with USP's Rules and Procedures of the Council of Experts ("Rules"), USP publishes all proposed revisions to the United States Pharmacopeia and the National Formulary (USP-NF) for public review and comment in the Pharmacopeial a1225n VALIDATION OF COMPENDIAL PROCEDURES Test procedures for assessment of the quality levels of pharmaceutical articles ar