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 Potency - Human Use | ||||||
Lethal/paralytic challenge test in the batch potency testing of tetanus toxoid vaccines for human use |
ELISA procedure for Batch Potency Testing of Tetanus Vaccines Description and references |
EU: Endorsed as valid by ECVAM (2000) |
EU: Accepted into PhEur (Method C, 2.7.8) (2003) | Reduction Refinement |
April 2009 | |
| Toxin Binding Inhibition (ToBI) Test for Batch Potency Testing of Tetanus Vaccines Description and references |
EU: Endorsed as valid by ECVAM (2000) | EU: Accepted into PhEur (Method C, 2.7.8) (2003) |
Reduction Refinement |
April 2009 | ||
Lethal/Intradermal Challenge Test in the Batch Potency Testing of Diptheria Vaccine |
ELISA Procedure for Potency testing of Diphtheria Vaccines Description and references |
No information |
EU: Accepted into PhEur |
Reduction Refinement |
April 2009 | |
| Vero Cell Assay for Potency testing of Diphtheria Vaccines Description and references |
EU: Norwegian Medicines Agency presently conducting validation |
EU: Accepted into PhEur |
Reduction Refinement |
April 2009 | ||
Combination Tetanus and Diphtheria vaccines – separate serology tests for each vaccine |
Tetanus and Diphtheria Serology test – single test for combination vaccine Description and references |
No information |
EU: Accepted into PhEur | Reduction |
April 2009 | |
Potency Test of Hepatitis B Vaccine (Mouse) |
Serological Antigen Quantification Description and references |
No Information |
EU: Accepted into PhEur ( 2.7.15) | Reduction Refinement |
April 2009 | |
Serological Potency Test of Poliomyelitis (inactivated) Vaccine (Rat) |
Antigen quantification Description and references |
No Information |
EU: Accepted into PhEur | Replacement |
April 2009 | |
Lethal challenge test for Rabies Vaccine |
Single dilution assay Description and references |
No Information |
EU: Accepted into PhEur | Reduction |
April 2009 | |
| Humane Endpoints for Rabies Potency Testing Description and references |
US: ICCVAM initiative | EU: Accepted in PhEur US: Accepted (9 CFR 117.e) |
Refinement |
April 2009 | ||
List of Abbreviations
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