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 | |||
| Vaccine Safety - Human Use | ||||||
Abnormal Toxicity Test for Human Use Vaccines
|
Deletion of test |
No information |
EU: Accepted on condition of demonstrated consistency |
Replacement |
April 2009 | |
Oral Polio Neurovirulence Test |
Mutant Analysis by PCR and Restriction Enzyme Cleavage, (MAPREC test) |
WHO: Validated for type 3 oral polio virus vaccines |
No information |
Reduction |
April 2009 | |
TgPVR21 Mouse Neurovirulence Test |
WHO: Validated for types 1, 2 and 3 oral polio virus vaccines (2003) |
No information |
Replacement |
March 2011 | ||
Residual Toxicity in Diptheria Vaccine (Guinea pig) |
Vero Cell Test of Diphtheria Toxoid Vaccines |
No information |
EU: Accepted into PhEur |
Replacement |
April 2009 | |
List of Abbreviations
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