RT Journal Article
SR Electronic
T1 Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 501
OP 511
DO 10.5731/pdajpst.2023.012871
VO 78
IS 4
A1 Walfish, Steven
A1 Duguid, John
A1 McCullough, Karen
YR 2024
UL http://journal.pda.org/content/78/4/501.abstract
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