This is an in vitro testing and date gathering exercise. The rabbit pyrogen test is the classical test for endotoxin. However, the in vitro Limulus Amebocyte Lysate (LAL) test is gradually replacing the rabbit. The LAL test besides being more specific for endotoxin than the rabbit it is also more quantitative. We are gathering data on biological products. It is our intention that over 90% of the products now being tested in rabbits will (in less than a year) be converted to the LAL test.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BR002001-16
Application #
6101322
Study Section
Special Emphasis Panel ( OD)
Project Start
Project End
Budget Start
Budget End
Support Year
16
Fiscal Year
1998
Total Cost
Indirect Cost