TRACKING SYSTEM FOR ALTERNATIVE METHODS TOWARDS REGULATORY ACCEPTANCE

TSAR indicates the stages methods have reached in terms of acceptance as a recognised test method for use in various sectors together with a summary description. Where available, TSAR also includes relevant records and documents associated with a method linked to the different steps of the entire process: submission, validation, peer-review, recommendations and regulatory acceptance including international standards represented in the tracking system.

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ELISA test for batch potency testing of tetanus vaccines for human use
TM Status: Closed
Test Method Number: TM1999-04 (EU)
Short Name of TM: ELISA TET
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Quality control of vaccines
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
In Vitro Pyrogen Test using Human Cryopreserved Whole Blood/IL-1 Beta
TM Status: Closed
Test Method Number: TM2002-02 (EU)
Short Name of TM: Cryo-WBT-IL1
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Pyrogenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
In Vitro Pyrogen Test using Human Whole Blood/IL-6
TM Status: Closed
Test Method Number: TM2002-05 (EU)
Short Name of TM: WBT-IL6
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Pyrogenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
In Vitro Pyrogen Test using MonoMac 6 cells/IL-6
TM Status: Closed
Test Method Number: TM2002-03 (EU)
Short Name of TM: MM6 IL6
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Pyrogenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards
In Vitro Pyrogen Test using Human Whole Blood/IL-1 Beta
TM Status: Closed
Test Method Number: TM2002-01 (EU)
Short Name of TM: WBT-IL1
Responsible Organisation: EURL ECVAM - European Union 
Topic(s): Pyrogenicity
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    Submission
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    Validation
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    Peer-review
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    Recommendation
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    Regulatory acceptance/Standards