Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES

Titel:
Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
Internet:

https://www.gmp-navigator.com/files/guidemgr/GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING.pdf

Herkunft/Verlag:

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

Dokumentenart:
Guideline
Inhalt:
Dieser Guideline befasst sich mit den Problemstellunge bei der Demonstration der Vergleichbarkeit gleichartiger Biologika die mittels rekombinanter DNA hergestellte Proteine enthalten.

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