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Eudralex Volume 3 The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guideline
Content:
This guideline lays down the requirements to be addressed in any justification for use of a test for bacterial endotoxins as an alternative to a test for pyrogens for plasma derived medicinal products.

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