Lethal/paralytic challenge test in the batch potency testing of tetanus toxoid vaccines for human use
(Methods A and B in PhEur 2.7.8) |
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
(single-dilution test instead of multi-dilution)
Refinement
(Does not rely on death as an endpoint)
|
May 2012 |
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)
US: 21 CFR 610.10 |
Reduction
(single-dilution test instead of multi-dilution)
Refinement
(Does not rely on death as an endpoint)
|
May 2012 |
Lethal/Intradermal Challenge Test in the Batch Potency Testing of Diphtheria Vaccine
(Methods A and B in PhEur 2.7.6) |
ELISA Procedure for Potency testing of Diphtheria Vaccines
Description and references |
No information |
EU: Accepted into PhEur |
Reduction Refinement |
May 2012 |
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 |
May 2012 |
| 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 |
May 2012 |
| Potency Test of Hepatitis B Vaccine (Mouse) |
Serological Antigen Quantification
Description and references |
No information |
EU: Accepted into PhEur (2.7.15) |
Reduction Refinement |
May 2012 |
| Serological Potency Test of Poliomyelitis (inactivated) Vaccine (Rat) |
Antigen quantification
Description and references |
No information |
EU: Accepted into PhEur |
Replacement |
May 2012 |
| Lethal challenge test for Rabies Vaccine |
Single dilution assay
Description and references |
No information |
EU: Accepted into PhEur |
Reduction |
May 2012 |
Humane Endpoints for Rabies Potency Testing
Description and references |
US: ICCVAM initiative |
EU: Accepted in PhEur
US: Accepted (9 CFR 117.e) |
Refinement |
May 2012 |
