Alternative Test Methods: Validation and Regulatory Status

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
Description and references

No information

 

EU: Accepted on condition of demonstrated consistency

Replacement

April 2009

Oral Polio Neurovirulence Test
(Monkey intracerebral)

Mutant Analysis by PCR and Restriction Enzyme Cleavage, (MAPREC test)
Description and references

WHO: Validated for type 3 oral polio virus vaccines

 

No information

Reduction

April 2009

TgPVR21 Mouse Neurovirulence Test
Description and references

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
Description and references

No information

 

EU: Accepted into PhEur

Replacement

April 2009

List of Abbreviations