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[1] Bruschke C J, Pittman M, Laddomada A. International regulations and standards for avian influenza, including the vaccine standards of the World Organisation for animal health. Rev Sci Tech, 2009, 28(1): 379-389.
[2] Elsken L A, Carr M Y, Frana T S, et al. Regulations for vaccines against emerging infections and agrobioterrorism in the United States of America. Rev Sci Tech, 2007, 26(2): 429-441.
[3] Sheridan C. Vaccine market boosters. Nat Biotechnol, 2009, 27(6): 499-501.
[4] Stalder J, Costanzo A, Daas A, et al. Establishment of a biological reference preparation for hepatitis A vaccine (inactivated, non-adsorbed). Pharmeur Bio Sci Notes, 2010, 2010(1): 15-29.
[5] Belak S. Molecular diagnosis of viral diseases, present trends and future aspects a view from the OIE Collaborating Centre for the application of polymerase chain reaction methods for diagnosis of viral diseases in veterinary medicine. Vaccine, 2007, 25(30): 5444-5452.
[6] Egan W, Schild G. New Cells for New Vaccines II: Focus on Respiratory Virus Diseases. Biologicals, 2008, 36(6): 345.
[7] Mutinelli F. European legislation governing the authorization of veterinary medicinal products with particular reference to the use of drugs for the control of honey bee diseases. Apiacta, 2003, 38: 156.
[8] Sheridan S, Coughlin J. Comparison of requirements in the European Union and United States of America for pre-clinical viral safety testing of veterinary vaccines. Biologicals, 2010, 38(3): 340-345.
[9] Kr mer B, Schildger H, Behrensdorf-Nicol H A, et al. The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines. Biologicals, 2009, 37(2): 119-126.
[10] Leifer I, Everett H, Hoffmann B, et al. Escape of classical swine fever C-strain vaccine virus from detection by C-strain specific real-time RT-PCR caused by a point mutation in the primer-binding site. J Virol Methods, 2010, 166(1-2): 98-100.
[11] Jones P G, Cowan G, Gravendyck M, et al. Regulatory requirements for vaccine authorisation. Rev Sci Tech, 2007, 26(2): 379-393.
[12] Whitney E A, Ailes E, Myers L M, et al. Prevalence of and risk factors for serum antibodies against Leptospira serovars in US veterinarians. J Am Vet Med Assoc, 2009, 234(7): 938-944.
[13] Hendriksen C, Arciniega J L, Bruckner L, et al. The consistency approach for the quality control of vaccines. Biologicals, 2008, 36(1): 73-77.
[14] Espeseth D A, Lasher H. Early history of regulatory requirements for poultry biologics in the United States. Avian Dis, 2010, 54(4): 1136-1143.
[15] Clark L, Lebwohl M. The effect of weight on the efficacy of biologic therapy in patients with psoriasis. J Am Acad Dermatol, 2008, 58(3): 443-446.
[16] Soulebot J P. Fedesa’s point of view: quality, application to IVMPs (immunological veterinary medicinal products). Dev Biol Stand, 1992, 79: 201-211.
[17] Draayer H A, Hilsabeck L J, Miller R H. The American manufacturer's view on the EEC texts and harmonization. Dev Biol Stand, 1992, 79: 77-83.
[18] Rweyemamu M M, Astudillo V M. Global perspective for foot and mouth disease control. Rev Sci Tech, 2002, 21(3): 765-773.
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