Alternative Test Methods: Validation and Regulatory Status
- Acute Aquatic Toxicity
- Acute Mammalian Oral Toxicity
- Acute Mammalian Inhalation Toxicity
- Acute Mammalian Skin Toxicity
- Biologics (non-vaccine)
- Carcinogenicity
- Chronic/Repeated Dose Toxicity
| Conventional test method | Alternative Test Method | Infor- mation Last Updated | ||||
|---|---|---|---|---|---|---|
| Name & Description | Validation Status | Regulatory Status | Effect or Potential Effect on Animal Use | |||
| Pyrogenicity | ||||||
Rabbit Pyrogen Test (RPT) |
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 |
April 2009 | |
| 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 endotoxin (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 |
April 2009 | ||
| MM6 IL – 6 In Vitro Pyrogen Test Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxin (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 |
April 2009 | ||
| PBMC IL - 6 In Vitro Pyrogen Test Description and references |
EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxin (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 |
April 2009 | ||
| 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 endotoxin (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 |
April 2009 | ||
| 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 |
April 2009 | ||
| 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 |
April 2009 | |
List of Abbreviations
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