Refinement and validation of an alternative bioassay for potency testing of therapeutic botulinum type A toxin

Pharmacology and Toxicology

Volumn 78, Issue 5, 1996, Pages 283-288

  Sesardic, Dorothea ^a   McLellan, Kay ^a   Ekong, Theresa A N ^a   Gaines Das, Rose ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BOTULINUM TOXIN A; NEUROMUSCULAR BLOCKING AGENT; NEUROTOXIN;

ANIMAL EXPERIMENT; ARTICLE; BIOASSAY; CLOSTRIDIUM BOTULINUM; CONTROLLED STUDY; DOSE RESPONSE; DRUG POTENCY; FEMALE; INTERMETHOD COMPARISON; LD 50; LETHALITY; MOUSE; MUSCLE SPASM; NEUROMUSCULAR DISEASE; NONHUMAN; PARALYSIS; PRIORITY JOURNAL; SUBCUTANEOUS DRUG ADMINISTRATION;

ANIMALIA; CLOSTRIDIA; CLOSTRIDIUM BOTULINUM;

EID: 0029952424     PISSN: 09019928     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1600-0773.1996.tb01376.x     Document Type: Article

References (24)

1. Balls, M. & D. W. Straughan: The three R's of Russell & Burch and the tesing of biological products. Dev. Biol. Stand. 1996, 86, 11-18.
2. Blasi, J., E. R. Chapman, E. Link, T. Binz, S. Yamasiki, P. DeCamilli, T. C. Sudhof, H. Niemann & R. Jahn: Botulinum neurotoxin A selectively cleaves the synaptic protein SNAP-25. Nature 1993, 365, 160-163.
3. Boroff, D. A. & U. Fleck: Statistical analysis of a rapid in vivo method for the titration of the toxin of Clostridium Botulinum. J. Bacteriol. 1966, 92, 1580-1581.
4. Brin, M. F. & A. Britzer: Botulinum toxin: Dangerous terminology errors (Letter). J. Royal Soc. Med. 1993, 86, 493-494.
5. 50) and acute toxicity testing. Toxicol. Lett. 1989, 49, 159-170.
6. Finney, D. J.: Probit analysis. 3rd ed. Cambridge University Press, 1971.
7. Finney, D. J.: Statistical methods in biological assay, 3rd ed. Charles Griffin & Co. Ltd., 1978.
8. Gonnering, R. S.: Pharmacology of botulinum toxin. Int. Ophthalmol. Clin. 1993, 33, 203-226.
9. Hambleton, P.: Clostridium botulinum toxin: a general review of involvement in disease, structure, mode of action and preparation for clinical use. J. Neurol. 1992, 239, 16-20.
10. Jankovich, J. & M. F. Brin: Therapeutic uses of botulinum toxin. New Engl. J. Med. 1991, 324, 1186-1194.
11. Kirkwood, T. B. L.: Geometric means and measures of dispersion (Letter). Biometrics 1979, 35, 908.
12. Lamanna, C., L. Spero & E. J. Schantz: Dependence of time to death on molecular size of botulinum toxin. Infect. Immun. 1970, 1, 423-424.
13. Miles, A. A.: Biological standards and the measurement of therapeutic activity. Brit. Med. Bull. 1951, 7, 283-291.
14. Pearce, L. B., G. E. Borodic, E. R. First & R. D. MacCallum: Measurement of botulinum toxin activity: evaluation of the lethality assay. Toxicol. Appl. Pharmacol. 1994, 128, 69-77.
15. Schantz, E. J. & E. A. Johnson: Properties and use of botulinum toxin and other microbial neurotoxins in medicine. Microbiol. Rev. 1992, 56, 80-99.
16. Schantz, E. J., D. A. Kautter. Microbiological methods: standardized assay for clostridium botulinum toxins. J. Ass. of Anal. Chem. 1978, 61, 96-99.
17. Scott, A. B.: Botulinum toxin injections of eye muscles to correct strabismus. Trans. Amer. Ophthalmol. Soc. 1981, 79, 734-770.
18. Shone, C. C., C. P. Quinn, R. Wait, B. Hallis, S. G. Fooks & P. Hambleton: Proteolytic cleavage of synthetic fragments of vesicle-associated membrane protein isoform-2 by botulinum type B neurotoxin. Eur. J. Biochem. 1993, 217, 965-971.
19. Simpson, L. L.: The origin, structure and pharmacological activity of botulinum toxin. Pharmacol. Rev. 1981, 33, 155-188.
20. Sesardic, D., R. E. Gaines Das & M. J. Corbel: Botulinum toxin (Letter). J. Roy. Soc. Med. 1994, 87, 307.
21. Sesardic, D.: Requirements for valid alternative assays for testing of biological therapeutic agents. Devel. Biol. Standard. 1996, 86, 311-318.
22. Sugiyama, H., S. L. Brenner & B. R. DasGupta: Detection of Clostridium botulinum toxin by local paralysis elicited with intramuscular challenge. Appl. Microbiol. 1975, 30, 420-423.
23. Takahashi, M., S. Kameyama & G. Sakaguchi: Assay in mice for low levels of Clostridium botulinum toxin. Int. J. Food Microbiol. 1990a, 11, 271-278.
24. Takahashi, M., T. Komiya, S. Kameyama & G. Sakaguchi: Titration of botulinum antitoxin of low levels by the score method. Jap. J. Med. Sci. Biol. 1990b,43, 163-170.