The role of bioassays in the development, licensing and batch control of biotherapeutics

Trends in Biotechnology

Volumn 14, Issue 4, 1996, Pages 121-124

  Jeffcoate, Stephen ^a  

^a Biological Consultants of Dorking   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

BIOASSAY; BIOTECHNOLOGY; DRUG CONTROL; DRUG EFFICACY; DRUG SAFETY; HUMAN; LICENSING; PRIORITY JOURNAL; QUALITY CONTROL; SHORT SURVEY;

EID: 0029917256     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/0167-7799(96)10018-4     Document Type: Article

References (10)

1. FDA (1987) Code of Federal Regulations 21 CFR 600, 3
2. Anon. (1975) United Kingdom Biological Standards Act, HMSO
3. WHO Expert Committee on Biological Standardization (1992) Technical Report Series 822, Annex 2
4. WHO Expert Committee on Biological Standardization (1991) Technical Report Series 814, Annex 3
5. WHO Expert Committee on Biological Standardization (1992) Technical Report Series 822, Annex 4
6. Mulligan, R. C. (1993) Science 260, 926-932
7. Jeffcoate, S. L. (1995) in The Year Book of the Royal College of Obstetricians and Gynaecologists, 1994 (Studd, J., ed.), pp. 55-67, RCOG Press
8. Bristow, A. F. and Jeffcoate, S. L. (1992) Biologicals 20, 221-231
9. Finney, D. J. (1978) Statistical Method in Biological Assay (3rd edn), Griffin
10. Barnett, V. and Lewis, T. (1994) Outliers in Statistical Data (3rd edn), John Wiley & Sons