Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing
Posted on March 7, 2023
Karen Zink McCullough, Owner, Principal Consultant, MMI Associates, LLC
Prologue This year (2023) marks the 50th anniversary of the first Federal Register notice regarding the “new” Limulus Amebocyte Lysate (LAL) test1. That first notice acknowledged the potential utility of the LAL test as both an in vitro diagnostic (IVD) for endotoxemia and as a tool for monitori...
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