Preparation and standardization of U.S. Standard Pertussis Vaccine, Lot No. 11

Biologicals

Volumn 24, Issue 4, 1996, Pages 363-370

  Jansen, Deborah L ^a   Meade, Bruce D ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

PERTUSSIS VACCINE;

ARTICLE; DRUG POTENCY; PRIORITY JOURNAL; STANDARDIZATION; UNITED STATES;

EID: 0030436248     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1006/biol.1996.0051     Document Type: Article

References (15)

1. 1. Medical Research Council. The prevention of whooping-cough by vaccination. Br Med J 1951; 1: 1463-1471.
2. 2. Medical Research Council. Vaccination against whooping-cough; relation between protection in children and results of laboratory tests. Br Med J 1956; 2: 454-462.
3. 3. Medical Research Council. Vaccination against whooping-cough: final report. Br Med J 1959; 1: 994-1000.
4. 4. Kendrick PL, Eldering G, Dixon MK et al. Mouse protection tests in the study of pertussis vaccine: a comparative series using the intracerebral route for challenge. Am J Publ Health 1947; 37: 803-810.
5. 5. Cowell JL, Hewlett EL, Manclark CR. Intracellular localization of the dermonecrotic toxin of Bordetella pertussis. Infect Immun 1979; 25: 896-901.
6. 6. United States Code of Federal Regulations, Title 21, Part 620.5.
7. 7. Manclark CR, Meade BD, Burstyn DG. Serological response to Bordetella pertussis. In: Rose NR, Friedman H, Fahey JL, eds, Manual of Clinical Laboratory Immunology, 3rd Edn. American Society for Microbiology, Washington DC, 1986, pp. 388-394.
8. 8. US Code of Federal Regulations, Title 21, Part 610.12(d)(1).
9. 9. May JC, Wheeler RM, Etz N et al. Measurement of final container residual moisture in freeze-dried biological products. Dev Biol Standard 1992; 74: 153-164.
10. 10. May JC, Grim E, Wheeler RM et al. Determination of residual moisture in freeze-dried viral vaccines: Karl Fischer, gravimetric and thermogravimetric methodologies. J Biol Stand 1982; 10: 249-259.
11. 11. May JC, Sih JTC. Protein nitrogen unit precipitation procedure for allergenic extracts: collaborative study. J Assoc Off Anal Chem 1981; 64: 1435-1438.
12. 12. US Code of Federal Regulations, Title 21, Part 620.4.
13. 13. Seagroatt V, Sheffield F. A collaborative assay of the proposed second International Standard for Pertussis Vaccine and of the proposed first British Standard for Pertussis Vaccine. J Biol Stand 1981; 9: 351-365.
14. 14. Finney DJ. Statistical Methods in Biological Assay, 3rd Edn. Charles Griffin and Co. Ltd, London, 1978.
15. 15. WHO Expert Committee on Biological Standardization. Biologic products. WHO Tech Rep Ser 1990; 800: 181-213.