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Biologics and Vaccines: Botulinum Toxin Testing

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References

Key Reference List for the HSUS Botulinum Toxin Nomination

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Appendix A

H Aoki. 2001. A comparison of the safety margins of botulinum neurotoxin serotypes A, B, and F in mice. Toxicon 39:1815-1820.

H Aoki. 2002. Botulinum neurotoxin serotypes A and B preparations have different safety margins in preclinical models of muscle weakening efficacy and systemic safety. Toxicon 40:923-928.

J Barr, H Moura, A Boyer, A Woolfitt, S Kalb, A Pavlopoulos, L McWilliams, J Schmidt, R Martinez, D Ashley. 2005. Botulinum neurotoxin detection and differentiation by mass spectrometry. Emerging Infectious Diseases 11:1578-1583.

H Bigalke, K Wohlfarth, A Irmer, R Dengler. 2001. Botulinum A toxin: Dysport improvement of biological availability. Experimental Neurology 168:162-170.

A Boyer, H Moutar, A Wootfittr, S Kalbrt, L McWilliams, A Pavlopoulos, J Schmidt , D Ashtey, J Barr. 2005. From the mouse to the mass spectrometer: Detection and differentiation of the endoproteinase activities of botulinum neurotoxins A-G by mass spectrometry. Anal. Chem. 77:3916-3924.

M Dong, W Tepp, E Johnson, E Chapman. 2004. Using fluorescent sensors to detect botulinum neurotoxin activity in vitro and in living cells. PNAS 101:14701-14706.

T Ekong, I Feavers, D Sesardic. 1997. Recombinant SNAP-25 is an effective substrate for Clostridium botulinum type A toxin endopeptidase activity in vitro. MicrobioIogy 143:3337-3347.

G Ferracci, R Miquelis, S Kozaki, M Seagar, C Leveque. 2005. Synaptic vesicle chips to assay botulinum neurotoxins. Biochem. J. 391:659-666.

S Kalandakanond, J Coffield. 2001. Cleavage of intracellular substrates of botulinum toxins A, C, and D in a mammalian target tissue. Pharmacology and Experimental Therapeutics 296:749-755.

L Pearce, G Borodic, E First, R MacCallum. 1994. Measurement of botulinum toxin activity: Evaluation of the lethality assay. Toxicology and Applied Pharmacology 128:69-77.

L Pearce, G Borodic, E Johnson, E First, R MacCallum. 1995. The median paralysis unit: A more pharmacologically relevant unit of biologic activity for botulinum toxin. Toxicon 33:217-227.

L Pearce, E First, R MacCallum, A Gupta. 1997. Review article: Pharmalogic characterization of botulinum toxin for basic science and medicine. Toxicon 35:1373-1412.

M Takahashi, S Kameyama, G Sakaguchi. 1990. Assay in mice for low levels of Clostridium botulinum toxin. International Journal of Food Microbiology 11:271-278.

M Wictome, K Newton, K Jameson, B Hallis, P Dunnigan, E Mackay, S Clarke, R Taylor, J Gaze, K Foster, C Shone. 1999. Development of an in vitro bioassay for Clostridium botulinum type B neurotoxin in foods that is more sensitive than the mouse bioassay. Applied and Environmental Microbiology 65:3787-3792.

Appendix B

K McLellan, R Das, T Ekong, D Sesardic. 1996. Therapeutic botulinum type A toxin: Factors affecting potency. Toxicon 34:975-985.

D Sesardic, T Leung, R Das. 2003. Role for standards in assays of botulinum toxins: international collaborative study of three preparations of botulinum type A toxin. Biologicals 31:265-276.

Appendix C

M Balls. 2003. Botulinum toxin testing in animals: The questions remain unanswered. ATLA 31:611-615.

M Balls, M Stephens. In press. What price vanity? The urgent need to replace painful animal potency tests for botulinum toxin products. Soap, Perfumery & Cosmetics.

K Bottrill. 2003. Growing old disgracefully: The cosmetic use of botulinum toxin. ATLA 31:381-391.

R Das, A Heath, H Martin, D Sesardic. 1999. Validation of in vitro assays for botulinum toxin: A case study. In: Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use (Brown F, Hendriksen C, Sesardic D, eds). Dev Biol Stand, Vol. 101. Basel:Karger, 267-276.

D Sesardic, R Jones, T Leung, T Alsop, R Tierney. 2004. Detection of antibodies against botulinum toxins. Movement Disorders 19: S85-S91.

M Stephens, M Balls. In Press. LD50 testing of botulinum toxin for use as a cosmetic. ALTEX.


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