Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Regulatory considerations when developing biological products. Report of the Center for Biologics Evaluation and Research
Inhoud in het Engels
Samenvatting
The Center for Biologics Evaluation and Research, whose regulatory authority includes monoclonal antibodies, cytokines, vaccines, toxins and somatic cellular therapies, communicates to sponsors issues for consideration in the development of biological products through the publication of "Points to Consider" and "Guideline" documents. This paper summarizes the available "Points to Consider" and "Guideline" documents and outlines recommendations from these documents for characterizing the cells used to produce biological products.
Prognia vat deze richtlijn samen als naslag en voor onderwijs. Dit is geen medisch advies. Controleer altijd de officiële richtlijn en de geldende lokale protocollen voordat je ernaar handelt.
Studiemateriaal
In het kort
- Organisatie
- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
- Gepubliceerd
- 1992
- Regio
- United States
- Taal
- English
- DOI
Meer binnen farmacologie
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