Overcoming obstacles to monoclonal antibody product development and approval

Trends in Biotechnology

Volumn 15, Issue 3, 1997, Pages 88-90

  Stein, Kathryn E ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ANTIBODY PRODUCTION; ANTIBODY SPECIFICITY; CLINICAL TRIAL; DRUG DEVELOPMENT; DRUG RESEARCH; DRUG SAFETY; HUMAN; PRIORITY JOURNAL; SHORT SURVEY;

EID: 0031104823     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-7799(96)10075-5     Document Type: Article

References (3)

1. 1 Köhler, G. and Milstein, C. (1975) Nature 256, 495-497
2. 2 Food and Drug Administration (1994) Points to Consider in the Manufacture and Testing of Monoclonal Antibodies for Human Use
3. 3 Food and Drug Administration (1996) FDA Guidance Concerning Demonstration of Comparability of Human Biological Products Including Therapeutic Biotechnology-derived Products