a1225n VALIDATION OF COMPENDIAL PROCEDURES Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP-NF constitute legal standards. 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. 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.) USP's mission is to improve global health through public standards and related programs. Protecting people from poor-quality medicines. Learn about the Promoting the Quality of Medicines (PQM) program, funded by USAID and implemented by USP. Download full list as: EXCEL | PDF. 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 As new biological drug products and new technologies emerge, the scope of bioassay approaches is likely to expand. Therefore, general chapter Biological Assay Validation 1033 emphasizes validation approaches that provide flexibility to adopt new bioassay methods, new biological drug products, or both in conjunction for the assessment of drug DSC USP-NF General Chapters25 USP-NF General Chapters This sec