Guideline for validation of the LAL test as an end-product endotoxin test for human and biological drug products
Munson, T.E.
Progress in Clinical and Biological Research 189: 211-220
1985
ISSN/ISBN: 0361-7742 PMID: 4048205 Document Number: 243330
The draft guideline sets forth acceptable conditions for use of the Limulus Amebocyte Lysate (LAL) test. It also describes procedures for using this methodology as an end-product endotoxin test for human (including biological products) and animal injectable drugs, and medical devices. Manufacturers are allowed to switch from the rabbit pyrogen test to the LAL test, without preclearance from FDA, if they follow the guideline.
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