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A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacture

Author
LEWIS, A. M1 ; KRAUSE, P1 ; PEDEN, K1
[1] Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food And Drug Administration, Bethesda, MD, United States
Conference title
Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development
Conference name
Evolution of Cell Substrates Used in the Manufacture of Biological's. Workshop (Rockville, Maryland 1999-09-07)
Author (monograph)
BROWN, Fred (Editor)1 ; LEWIS, Andrew (Editor)2 ; KRAUSE, Philip (Editor)2 ; PEDEN, Keith (Editor)2
Center for biologics Evaluation and Research (CBER), Bethesda, MD (Funder/Sponsor)
International Association for Biologicals (IABs), International (Funder/Sponsor)
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, United States (Funder/Sponsor)
National Vaccine Program Office (NVPO) (Funder/Sponsor)
World Health Organization (WHO), Geneva, Switzerland (Funder/Sponsor)
[1] Plum Island Disease Center, Greenport, New York, United States
[2] Division of Viral Products, CBER/FDA/DHHS, 29 Lincoln Drive, Bethesda, MD 20892
Source

Developments in biologicals. 2001, Vol 106, pp 513-535 ; ref : 61 ref

ISSN
1424-6074
Scientific domain
Biochemistry, molecular biology, biophysics; Medical laboratory techniques; Microbiology, infectious diseases
Publisher
Karger, Basel / Karger, Freiburg / Karger, Paris
Publication country
Switzerland
Document type
Conference Paper
Language
English
Keyword (fr)
Tumeur maligne Utilisation Vaccin
Keyword (en)
Malignant tumor Use Vaccine
Keyword (es)
Tumor maligno Utilización Vacuna
Classification
Pascal
002 Biological and medical sciences / 002A Fundamental and applied biological sciences. Psychology / 002A05 Microbiology

Discipline
Microbiology
Origin
Inist-CNRS
Database
PASCAL
INIST identifier
14167218

Sauf mention contraire ci-dessus, le contenu de cette notice bibliographique peut être utilisé dans le cadre d’une licence CC BY 4.0 Inist-CNRS / Unless otherwise stated above, the content of this bibliographic record may be used under a CC BY 4.0 licence by Inist-CNRS / A menos que se haya señalado antes, el contenido de este registro bibliográfico puede ser utilizado al amparo de una licencia CC BY 4.0 Inist-CNRS

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