Validation of Test Result Equivalence for Alternative BET assays...

Presented by

Karen Zink McCullough, at MMI Associates, John Duguid, at Vericel Corporation and Steven Walfish, at Outsourcing Services

About this talk

Full title: Validation of Test Result Equivalence for Alternative BET assays, Including Recombinant Methods Both FDA’s 2012 Guidance for Industry and USP <1223> specifically use the term, “equivalence” as a requirement for validating an alternative test. Traditional methods, such as the Limulus amebocyte lysate (LAL) assay, are widely accepted and have a proven record of assuring parenteral drug and device safety, but they have limitations, including reagent variability and sustainability concerns. As a result, new methods using a number of innovative platforms, including recombinant technology (rFC and rCR), have emerged. The concept of test result equivalence bridges the gap between old and new technologies, offering cost-effective, environmentally friendly, and reproducible means of endotoxins detection, advancing the industry's ability to ensure continued product quality and patient safety.  This webinar will explore the concepts of equivalence, comparability, and statistical methods used to evaluate them.

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