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
Contenu en anglais
Synthèse
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 résume cette recommandation à des fins de consultation et d’enseignement. Il ne s’agit pas d’un avis médical. Vérifiez toujours la recommandation officielle et les protocoles locaux en vigueur avant de l’appliquer.
Supports pédagogiques
En bref
- Organisme
- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
- Date de publication
- 1992
- Région
- United States
- Langue
- English
Autres recommandations en pharmacologie
- Practical guidelines for preparing and administering amphotericin B.European Respiratory Society · 1992
- Hospital pharmacy compliance with JCAHO standards and ASHP guidelines for reporting adverse drug reactionsEuropean Respiratory Society · 1992
- Measurement of final container residual moisture in freeze-dried biological products
