Elaboration of Certification Procedures for Reference Standards of Biological Drugs

Abstract

Reference standards (RSs) are necessary to standardize medicinal products, including biological drugs, and are key factors of their efficacy and safety. Experience in certification of biological RSs and an analysis of foreign and national guidelines concerning the certification procedure for biological RSs were used as a basis to propose an improved order of attestation for RSs used for quality control of biological drugs. The general statistical approaches for assessing the test results obtained during the determination of the certified characteristics of the biological RSs and their uncertainties are described.