Rabbit Pyrogen Test (RPT)
(USP 151) |
Human Whole Blood IL -1 In Vitro Pyrogen Test
Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxins (2006)
US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)
|
No information |
Replacement
(when used to test for Gram-negative endotoxins) |
May 2012 |
Human Whole Blood IL -6 in Vitro pyrogen test
Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxins (2006)
US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)
|
No information |
Replacement
(when used to test for Gram-negative endotoxins) |
May 2012 |
MM6 IL – 6 In Vitro Pyrogen Test
Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxins (2006)
US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)
|
No information |
Replacement
(when used to test for Gram-negative endotoxins) |
May 2012 |
PBMC IL - 6 In Vitro Pyrogen Test
Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxins (2006)
US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)
|
No information |
Replacement
(when used to test for Gram-negative endotoxins) |
May 2012 |
Human Cryopreserved Whole Blood IL-1 In Vitro Pyrogen Test
Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxins (2006)
US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)
|
No information |
Replacement
(when used to test for Gram-negative endotoxins) |
May 2012 |
Limulus Amebocyte Lysate (LAL) Test a.k.a. Bacterial Endotoxin Test
Description and references |
EU/US/Japan: To use test for regulatory purposes; an “in-house” validation program is required |
EU: Accepted by EU and listed in the EDQM/European Pharmacopeia (5.0)
US: Accepted by the FDA and listed in the United States Pharmacopeia (USP 85)
Japan: Listed in Japanese Pharmacopeia XIV
|
Replacement
(Relative replacement: replacing more sentient animals with animals that current scientific peer advice and interpretation of scientific evidence indicate have a lower potential for pain perception) |
May 2012 |
Limulus Amebocyte
Lysate (LAL) Test a.k.a. Bacterial Endotoxin Test |
Recombinant Factor C (rFC) Bacterial Endotoxin Test
Description and references |
US: Currently being compared to the Bacterial Endotoxin Test for inclusion in the USP |
No information |
Replacement |
May 2012 |
