The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
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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