PT - JOURNAL ARTICLE AU - Walfish, Steven AU - Duguid, John AU - McCullough, Karen TI - Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods AID - 10.5731/pdajpst.2023.012871 DP - 2024 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 501--511 VI - 78 IP - 4 4099 - http://journal.pda.org/content/78/4/501.short 4100 - http://journal.pda.org/content/78/4/501.full SO - PDA J Pharm Sci Technol2024 Jul 01; 78 AB - The LAL test has been the “gold standard” for endotoxin testing ever since it was first published as USP Chapter <85> in 1980. Since then, a number of innovative methods have been proposed to augment or replace the LAL test. However novel an alternate test method might be, we must be cognizant of our obligation to patient safety and heed compendial and compliance requirements to demonstrate results equivalence between any candidate (alternate) method and a predicate (compendial) test method. The following discussion explores the concepts of “equivalent”, “different” and “not different”, proposes the use of a two one sided test (TOST) for the demonstration of equivalence and provides examples of calculations using commercially available software to assess data on alternative endotoxins detection methods that have been published in the public domain1