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Volumn 5, Issue , 2011, Pages 16-32

Non-animal replacement methods for human vaccine potency testing: State of the science and future directions

Author keywords

Human vaccines; ICCVAM; Replacement alternatives; Vaccine potency testing; Vaccine safety testing

Indexed keywords

ACELLULAR VACCINE; ANTHRAX VACCINE; BACTERIAL VACCINE; BRUCELLA VACCINE; CHLAMYDOPHILA FELIS VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; ERYSIPELOTHRIX RHUSIOPATHIAE VACCINE; FELINE CALICIVIRUS VACCINE; HEPATITIS A VACCINE; HEPATITIS B VACCINE; MANNHEIMIA HAEMOLYTICA VACCINE; PERTUSSIS VACCINE; POLIOMYELITIS VACCINE; RABIES VACCINE; UNCLASSIFIED DRUG; VIRUS VACCINE;

EID: 84555217967     PISSN: None     EISSN: 1877282X     Source Type: Journal    
DOI: 10.1016/j.provac.2011.10.002     Document Type: Article
Times cited : (27)

References (112)
  • 1
    • 84855913966 scopus 로고    scopus 로고
    • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences. NIH Publication No. 08-6410.
    • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences, 2008. NIH Publication No. 08-6410. http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
    • (2008)
  • 2
    • 84555193333 scopus 로고    scopus 로고
    • Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol.(current issue).
    • Stokes WS, Kulpa-Eddy J, McFarland RM. Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Stokes, W.S.1    Kulpa-Eddy, J.2    McFarland, R.M.3
  • 8
    • 84555190338 scopus 로고    scopus 로고
    • Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions
    • Proc Vaccinol.(current issue).
    • Kulpa-Eddy J, Srinivas G, Halder M, Hill R, Brown K, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B, Stokes WS. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Kulpa-Eddy, J.1    Srinivas, G.2    Halder, M.3    Hill, R.4    Brown, K.5    Draayer, H.6    Galvin, J.7    Claassen, I.8    Gifford, G.9    Woodland, R.10    Doelling, V.11    Jones, B.12    Stokes, W.S.13
  • 9
    • 84555191831 scopus 로고    scopus 로고
    • Veterinary vaccines and their importance to animal health and public health
    • Proc Vaccinol (current issue).
    • Roth J. Veterinary vaccines and their importance to animal health and public health. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Roth, J.1
  • 10
    • 84555190332 scopus 로고    scopus 로고
    • Human vaccines and their importance to public health
    • Proc Vaccinol.(current issue).
    • Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Schuchat, A.1
  • 11
    • 84555190330 scopus 로고    scopus 로고
    • U.S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol(current issue).
    • Finn T. U.S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Finn, T.1
  • 12
    • 84555173562 scopus 로고    scopus 로고
    • USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol.(current issue).
    • Hill RE. USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Hill, R.E.1
  • 13
    • 84555196684 scopus 로고    scopus 로고
    • Health Canada's human vaccine lot release program: impact on the 3Rs. Proc Vaccinol (current issue).
    • Isbrucker R, Sontakke S, Smith D. Health Canada's human vaccine lot release program: impact on the 3Rs. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Isbrucker, R.1    Sontakke, S.2    Smith, D.3
  • 14
    • 84555217945 scopus 로고    scopus 로고
    • European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use
    • Proc Vaccinol.(current issue).
    • Woodland R. European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Woodland, R.1
  • 16
    • 84555196680 scopus 로고    scopus 로고
    • International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO perspective
    • Proc Vaccinol.(current issue).
    • Shin J, Lei D, Conrad C, Knezevic I, Wood D. International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO perspective. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Shin, J.1    Lei, D.2    Conrad, C.3    Knezevic, I.4    Wood, D.5
  • 17
    • 84555190324 scopus 로고    scopus 로고
    • Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use
    • Proc Vaccinol (current issue).
    • Draayer H. Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Draayer, H.1
  • 18
    • 84555217940 scopus 로고    scopus 로고
    • Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency. Proc Vaccinol .(current issue).
    • Claassen I. Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Claassen, I.1
  • 19
    • 84855980280 scopus 로고    scopus 로고
    • Overview of the current status of human vaccine potency testing methods that replace animals
    • Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September. Available at:
    • Levis R. Overview of the current status of human vaccine potency testing methods that replace animals. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
    • (2010)
    • Levis, R.1
  • 20
    • 84555198310 scopus 로고    scopus 로고
    • A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency
    • Proc Vaccinol.(current issue).
    • Descamps J, et al. A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Descamps, J.1
  • 21
    • 84555196668 scopus 로고    scopus 로고
    • Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing
    • Proc Vaccinol .(current issue).
    • Keller JE. Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Keller, J.E.1
  • 22
    • 84855928435 scopus 로고    scopus 로고
    • Refinement alternatives for veterinary vaccine potency testing: overview of currently approved serological methods
    • Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September Available at:
    • Srinivas G. Refinement alternatives for veterinary vaccine potency testing: overview of currently approved serological methods. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
    • (2010)
    • Srinivas, G.1
  • 23
    • 84555196669 scopus 로고    scopus 로고
    • Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines
    • Proc Vaccinol (current issue).
    • Stickings P, Rigsby P, Coombes L, Hockley J, Tierney R, Sesardic D. Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Stickings, P.1    Rigsby, P.2    Coombes, L.3    Hockley, J.4    Tierney, R.5    Sesardic, D.6
  • 24
    • 84555217934 scopus 로고    scopus 로고
    • Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine
    • Proc Vaccinol.(current issue).
    • Arciniega JL, Domínguez-Castillo RI. Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Arciniega, J.L.1    Domínguez-Castillo, R.I.2
  • 25
    • 84555217930 scopus 로고    scopus 로고
    • Humane endpoints in vaccine potency testing
    • Proc Vaccinol (current issue).
    • Hendriksen CFM. Humane endpoints in vaccine potency testing. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Hendriksen, C.F.M.1
  • 26
    • 84555191809 scopus 로고    scopus 로고
    • Examples of approaches to reducing animal numbers in vaccine potency testing
    • Proc Vaccinol .(current issue).
    • Kulpa-Eddy J, Srinivas G. Examples of approaches to reducing animal numbers in vaccine potency testing. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Kulpa-Eddy, J.1    Srinivas, G.2
  • 27
    • 84555190317 scopus 로고    scopus 로고
    • Application of the consistency approach in the United States to reduce animal use in vaccine potency testing
    • Proc Vaccinol (current issue).
    • Kulpa-Eddy J, Dusek D. Application of the consistency approach in the United States to reduce animal use in vaccine potency testing. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Kulpa-Eddy, J.1    Dusek, D.2
  • 28
    • 84555217925 scopus 로고    scopus 로고
    • Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives
    • Proc Vaccinol 2011.(current issue).
    • Gifford G, Agrawal P, Hutchings D, Yarosh O. Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Gifford, G.1    Agrawal, P.2    Hutchings, D.3    Yarosh, O.4
  • 29
    • 84555190312 scopus 로고    scopus 로고
    • Target alternative vaccine safety testing strategies for Pertussis toxin
    • Proc Vaccinol (current issue).
    • Arciniega JL, Corvette L, Hsu H, Lynn F, Romani T, Dobbelaer R. Target alternative vaccine safety testing strategies for Pertussis toxin. Proc Vaccinol 2011 (current issue).
    • (2011)
    • Arciniega, J.L.1    Corvette, L.2    Hsu, H.3    Lynn, F.4    Romani, T.5    Dobbelaer, R.6
  • 30
    • 84555191800 scopus 로고    scopus 로고
    • Toward replacement of the monkey neurovirulence test in vaccine safety testing
    • Proc Vaccinol .(current issue).
    • Rubin SA. Toward replacement of the monkey neurovirulence test in vaccine safety testing. Proc Vaccinol 2011.(current issue).
    • (2011)
    • Rubin, S.A.1
  • 31
    • 28744443427 scopus 로고    scopus 로고
    • Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001. Arch Pediatr Adolesc Med
    • Zhou FSJ, Messonnier ML, Yusuf HR, Shefer A, Chu SY, Rodewald L, Harpaz R. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001. Arch Pediatr Adolesc Med 2005;159(12):1136-44.
    • (2005) , vol.159 , Issue.12 , pp. 1136-1144
    • Zhou, F.S.J.1    Messonnier, M.L.2    Yusuf, H.R.3    Shefer, A.4    Chu, S.Y.5    Rodewald, L.6    Harpaz, R.7
  • 32
    • 84855925839 scopus 로고
    • Public Health Service Act. (as amended). 42 U.S.C. 6A. Available at:
    • Public Health Service Act. 1944 (as amended). 42 U.S.C. 6A. Available at: http://www.FDA.gov/RegulatoryInformation/Legislation/ucm148717.htm.
    • (1944)
  • 33
    • 84855925836 scopus 로고
    • Federal Food, Drug, and Cosmetic Act.(as amended). 21 U.S.C. 301 et seq. Available at:
    • Federal Food, Drug, and Cosmetic Act. 1938 (as amended). 21 U.S.C. 301 et seq. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm.
    • (1938)
  • 34
    • 84555198322 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 21, Food and Drugs. Part 600, Biological Products: General. Section 600.3.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 21, Food and Drugs. Part 600, Biological Products: General. Section 600.3. 2010.
    • (2010)
  • 35
    • 63849201560 scopus 로고    scopus 로고
    • Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement
    • Hendriksen CFM. Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement. Exp. Rev. Vaccines 2009;8:313-322.
    • (2009) Exp. Rev. Vaccines , vol.8 , pp. 313-322
    • Hendriksen, C.F.M.1
  • 36
    • 70349741294 scopus 로고    scopus 로고
    • Development and use of a novel in vitro assay for testing of diphtheria toxoid in combination vaccines
    • Coombes L, Stickings P, Tierney R, Rigsby P, Sesardic D. Development and use of a novel in vitro assay for testing of diphtheria toxoid in combination vaccines. J Immunol Methods 2009;350:142-149.
    • (2009) J Immunol Methods , vol.350 , pp. 142-149
    • Coombes, L.1    Stickings, P.2    Tierney, R.3    Rigsby, P.4    Sesardic, D.5
  • 37
    • 84555198298 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 20708. Assay of tetanus vaccine (adsorbed), Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 20708. Assay of tetanus vaccine (adsorbed), Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 38
    • 84555193318 scopus 로고
    • United States Minimum Requirements: Tetanus toxoid
    • United States Minimum Requirements: Tetanus toxoid, 1952.
    • (1952)
  • 39
    • 84555193311 scopus 로고    scopus 로고
    • World Health Organization. Annex 5. Recommendations for diphtheria, tetanus, pertussis and combined vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization,.(WHO Technical Report Series No. 927).
    • World Health Organization. Annex 5. Recommendations for diphtheria, tetanus, pertussis and combined vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005,.(WHO Technical Report Series No. 927).
    • (2005)
  • 40
    • 84555193310 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 20706. Assay of diphtheria vaccine (adsorbed), Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; .Ph Eur 2.7.6.
    • European Pharmacopoeia. Monograph 20706. Assay of diphtheria vaccine (adsorbed), Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.Ph Eur 2.7.6.
    • (2008)
  • 41
    • 84555198326 scopus 로고
    • United States Minimum Requirements: Diphtheria
    • United States Minimum Requirements: Diphtheria, 1947.
    • (1947)
  • 42
    • 84555198324 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 1356. Pertussis Vaccine Acellular Component, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
    • European Pharmacopoeia. Monograph 1356. Pertussis Vaccine Acellular Component, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 43
    • 84555193308 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 1595. Pertussis Vaccine Acellular, Copurified, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
    • European Pharmacopoeia. Monograph 1595. Pertussis Vaccine Acellular, Copurified, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 44
    • 84555172453 scopus 로고    scopus 로고
    • Japanese Minimum Requirements for Biological Products. National Institute of Infectious Diseases, Japan
    • Japanese Minimum Requirements for Biological Products. National Institute of Infectious Diseases, Japan 2006.
    • (2006)
  • 45
    • 84555172445 scopus 로고    scopus 로고
    • World Health Organization. Annex 2. Guidelines for the production and control of the acelluar pertussis compenent of monovalent or combined vaccines. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization,.(WHO Technical Report Series No. 878).
    • World Health Organization. Annex 2. Guidelines for the production and control of the acelluar pertussis compenent of monovalent or combined vaccines. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998,.(WHO Technical Report Series No. 878).
    • (1998)
  • 46
    • 84555198323 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 0216. Rabis vaccine for human use prepared in cell cultures, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 0216. Rabis vaccine for human use prepared in cell cultures, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 47
    • 84555193330 scopus 로고    scopus 로고
    • World Health Organization. Annex 2. Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs. In: WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization,.(WHO Technical Report Series No. 941).
    • World Health Organization. Annex 2. Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs. In: WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization, 2007,.(WHO Technical Report Series No. 941).
    • (2007)
  • 48
    • 84555172452 scopus 로고
    • The NIH test for potency. In: Laboratory techniques in rabies (Eds Kaplan MM and Koprowski H) 3rd edn. WHO, Geneva
    • Seligmann EB. The NIH test for potency. In: Laboratory techniques in rabies (Eds Kaplan MM and Koprowski H) 3rd edn. WHO, Geneva, 1973:279-286.
    • (1973) , pp. 279-286
    • Seligmann, E.B.1
  • 49
    • 0032621284 scopus 로고    scopus 로고
    • Release potency tests of hepatitis vaccines. In: Sesardic D, Brown F, Hendriksen CFM, editors. Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use. Meeting of the International Association of Biological Standardization. September. London. Dev Biol Stand (Basel): Karger
    • Descamps J, Mary A, Rommel E, Anhoury ML, De Neys R, Duchêne M. Release potency tests of hepatitis vaccines. In: Sesardic D, Brown F, Hendriksen CFM, editors. Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use. Meeting of the International Association of Biological Standardization. September 1998. London. Dev Biol Stand (Basel): Karger, 1999;100:289-94.
    • (1999) , vol.100 , pp. 289-294
    • Descamps, J.1    Mary, A.2    Rommel, E.3    Anhoury, M.L.4    De Neys, R.5    Duchêne, M.6
  • 50
    • 0037631377 scopus 로고    scopus 로고
    • Validation of an in vitro potency test for the Cuban hepatitis B vaccine
    • Landys Shovel Cuervo M and Reyes HN. Validation of an in vitro potency test for the Cuban hepatitis B vaccine. Dev Biol 2002;111:305-312.
    • (2002) Dev Biol , vol.111 , pp. 305-312
    • Landys, S.1    Cuervo, M.2    Reyes, H.N.3
  • 51
    • 84555193315 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 1935. Hepatitis A Vaccine Inactivated, Ph.Eur. 6th Edition. Strasbourg,;1; France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 1935. Hepatitis A Vaccine Inactivated, Ph.Eur. 6th Edition. Strasbourg,;1; France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 52
    • 84555193316 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 20701. Immunochemical methods, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 20701. Immunochemical methods, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 53
    • 84555173557 scopus 로고
    • World Health Organization. Requirements for Hepatitis A Vaccine Inactivated. In: WHO Expert Committee on Biological Standardization. Forty-fifth report. Geneva, World Health Organization,.(WHO Technical Report Series No. 858).
    • World Health Organization. Requirements for Hepatitis A Vaccine Inactivated. In: WHO Expert Committee on Biological Standardization. Forty-fifth report. Geneva, World Health Organization, 1995,.(WHO Technical Report Series No. 858).
    • (1995)
  • 54
    • 84555172450 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 1056. Hepatitis B Vaccine rDNA, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 1056. Hepatitis B Vaccine rDNA, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 55
    • 84555173552 scopus 로고    scopus 로고
    • Method of Analysis. Biological assays: Assay of hepatitis B vaccine (rDNA) [ch. 2.7.15]. In: European Pharmacopoeia, 67th ed. Strasbourg, France: European Department for the Quality of Medicines & HealthCare (EDQM), Council of Europe
    • Method of Analysis. Biological assays: Assay of hepatitis B vaccine (rDNA) [ch. 2.7.15]. In: European Pharmacopoeia, 67th ed. Strasbourg, France: European Department for the Quality of Medicines & HealthCare (EDQM), Council of Europe, 2011.
    • (2011)
  • 56
    • 84555198320 scopus 로고    scopus 로고
    • World Health Organization. Requirements for Hepatitis B Vaccine Inactivated. In: WHO Expert Committee on Biological Standardization. Forty-eighth report. Geneva, World Health Organization, (WHO Technical Report Series No. 889).
    • World Health Organization. Requirements for Hepatitis B Vaccine Inactivated. In: WHO Expert Committee on Biological Standardization. Forty-eighth report. Geneva, World Health Organization, 1999, (WHO Technical Report Series No. 889).
    • (1999)
  • 57
    • 84555173559 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 214. Poliomyelitis Vaccine Inactivated, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 214. Poliomyelitis Vaccine Inactivated, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 58
    • 84555173556 scopus 로고    scopus 로고
    • World Health Organization. Requirements for Oral Poliomyelitis Vaccine. In: WHO Expert Committee on Biological Standardization. Fifty-first report. Geneva, World Health Organization,.(WHO Technical Report Series No. 910).
    • World Health Organization. Requirements for Oral Poliomyelitis Vaccine. In: WHO Expert Committee on Biological Standardization. Fifty-first report. Geneva, World Health Organization, 2002,.(WHO Technical Report Series No. 910).
    • (2002)
  • 61
    • 0030049407 scopus 로고    scopus 로고
    • Rabies vaccine potency control: comparison of ELISA systems for antigenicity testing
    • Rooijakkers E.J., Uittenboogaard J.P., Groen J., Osterhaus A.D. Rabies vaccine potency control: comparison of ELISA systems for antigenicity testing. J Virol Methods 1996, 58:111-119.
    • (1996) J Virol Methods , vol.58 , pp. 111-119
    • Rooijakkers, E.J.1    Uittenboogaard, J.P.2    Groen, J.3    Osterhaus, A.D.4
  • 62
    • 84555172439 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph XXXX: 0451 - Rabies vaccine (inactivated) for veterinary use. Pharmeuropa
    • European Pharmacopoeia. Monograph XXXX: 0451 - Rabies vaccine (inactivated) for veterinary use. Pharmeuropa 2011;13:128-131.
    • (2011) , vol.13 , pp. 128-131
  • 63
    • 0038645935 scopus 로고    scopus 로고
    • Development of an in vitro potency test for tetanus vaccines: an immunoassay based on Hc fragment determination
    • Prieur S., Broc S., Gal M., Poirer B., Fuchs F. Development of an in vitro potency test for tetanus vaccines: an immunoassay based on Hc fragment determination. Dev Biol 2002, 111:37-46.
    • (2002) Dev Biol , vol.111 , pp. 37-46
    • Prieur, S.1    Broc, S.2    Gal, M.3    Poirer, B.4    Fuchs, F.5
  • 64
    • 0028618501 scopus 로고
    • Combination of DTP and Haemophilus influenzae type b conjugate vaccines can affect laboratory evaluation of potency and immunogenicity
    • Redhead K., Sesardic D., Yost S.E., Attwell A.M., Watkins J., Hoy C.S., Plumb J.E., Corbel M.J. Combination of DTP and Haemophilus influenzae type b conjugate vaccines can affect laboratory evaluation of potency and immunogenicity. Biologicals 1994, 22(4):339-345.
    • (1994) Biologicals , vol.22 , Issue.4 , pp. 339-345
    • Redhead, K.1    Sesardic, D.2    Yost, S.E.3    Attwell, A.M.4    Watkins, J.5    Hoy, C.S.6    Plumb, J.E.7    Corbel, M.J.8
  • 65
    • 0033380287 scopus 로고    scopus 로고
    • Mutual interactions between DTaP-IPV and Haemophilus influenzae type b (Hib)-conjugated vaccines in laboratory animal models
    • Shams H, Heron I. Mutual interactions between DTaP-IPV and Haemophilus influenzae type b (Hib)-conjugated vaccines in laboratory animal models. Biologicals 1999;27(3):227-240.
    • (1999) Biologicals , vol.27 , Issue.3 , pp. 227-240
    • Shams, H.1    Heron, I.2
  • 67
    • 84855913992 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.65. SAM 600: Supplemental Assay Method for Purity, Potency and Dissociation of Brucella abortus Vaccine, Strain l9
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.65. SAM 600: Supplemental Assay Method for Purity, Potency and Dissociation of Brucella abortus Vaccine, Strain l9. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 68
    • 84855933951 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.67. SAM 612: Supplemental Assay Method for Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.67. SAM 612: Supplemental Assay Method for Bacterial Plate Count of Erysipelothrix rhusiopathiae Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2007)
  • 69
    • 84855913993 scopus 로고    scopus 로고
    • Section 113.68. SAM 905: Supplemental Assay Method for Test for Potency of Live Avirulent Pasteurella haemolytica Vaccine.
    • Section 113.68. SAM 905: Supplemental Assay Method for Test for Potency of Live Avirulent Pasteurella haemolytica Vaccine. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_900_series.shtml.
    • (2009)
  • 70
    • 84855913991 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.71. SAM 319: Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.71. SAM 319: Supplemental Assay Method for Titration of Chlamydophila felis (formerly Feline Chlamydia psittaci) in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 71
    • 84855925835 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.314. SAM 306: Supplemental Assay Method for the Titration of Feline Calicivirus in Cell Culture.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.314. SAM 306: Supplemental Assay Method for the Titration of Feline Calicivirus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2008)
  • 72
    • 84855933948 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.315. SAM 307: Supplemental Assay Method for the Titration of Feline Rhinotracheitis Virus in Cell Culture.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.315. SAM 307: Supplemental Assay Method for the Titration of Feline Rhinotracheitis Virus in Cell Culture. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2008)
  • 73
    • 84855953221 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.330. SAM 406: Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2 or 3.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.330. SAM 406: Supplemental Assay Method for Titration of Monovalent, Cell Associated Marek's Disease Vaccines of Serotypes 1, 2 or 3. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
    • (2005)
  • 74
    • 84555193328 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:0589. Marek's disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 01/2008:0589. Marek's disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
    • (2010)
  • 75
    • 84855933949 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 114: Supplemental Assay Method for Titration of Porcine Transmissible Gastroenteritis Virus.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 114: Supplemental Assay Method for Titration of Porcine Transmissible Gastroenteritis Virus. 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
    • (2011)
  • 76
    • 84855953219 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 121: Supplemental Assay Method for Titration of Porcine Rotovirus In Modified-Live Vaccines.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 121: Supplemental Assay Method for Titration of Porcine Rotovirus In Modified-Live Vaccines. 2005. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
    • (2005)
  • 77
    • 84855953220 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.305. SAM 304: Supplemental Assay Method for Titration of Infectious Canine Hepatitis Virus in Primary Canine Kidney Cell Culture.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.305. SAM 304: Supplemental Assay Method for Titration of Infectious Canine Hepatitis Virus in Primary Canine Kidney Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 78
    • 84855925832 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.306. SAM 323: Supplemental Assay Method for Titration of Canine Distemper Virus in Vero Cell Culture
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.306. SAM 323: Supplemental Assay Method for Titration of Canine Distemper Virus in Vero Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 79
    • 84855933947 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.331. SAM 408: Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.331. SAM 408: Supplemental Assay Method for Titrating Tissue Culture Adapted Vaccine Strains of Infectious Bursal Disease Virus. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_400_series.shtml.
    • (2007)
  • 80
    • 84555172442 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:0587. Avian infectious bursal disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 01/2008:0587. Avian infectious bursal disease vaccine (live). 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
    • (2010)
  • 81
    • 0016912404 scopus 로고
    • Standard requirements for vaccines against infectious bursal disease
    • Thornton D.H. Standard requirements for vaccines against infectious bursal disease. Dev Biol Stand 1976, 33:343-348.
    • (1976) Dev Biol Stand , vol.33 , pp. 343-348
    • Thornton, D.H.1
  • 82
    • 84855925833 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.304. SAM 305: Supplemental Assay Method for Titration of Feline Panleukopenia Virus in Cell Culture.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.304. SAM 305: Supplemental Assay Method for Titration of Feline Panleukopenia Virus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 83
    • 84855925834 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.317. SAM 316. Supplemental Assay Method for the Titration of Canine Parvovirus in Cell Culture.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.317. SAM 316. Supplemental Assay Method for the Titration of Canine Parvovirus in Cell Culture. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 84
    • 84855933945 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.302. SAM 303: Supplemental Assay Method for the Titration of Distemper Virus in Embryonated Chicken Eggs
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.302. SAM 303: Supplemental Assay Method for the Titration of Distemper Virus in Embryonated Chicken Eggs. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 85
    • 84855933944 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 613: Supplemental Assay Method for In vitro Potency Testing of Erysipelothrix rhusiopathiae Bacterins
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 613: Supplemental Assay Method for In vitro Potency Testing of Erysipelothrix rhusiopathiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 86
    • 84855933946 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 611: Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.119. SAM 611: Supplemental Assay Method for Potency Testing of Erysipelas Bacterins in Mice. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2008)
  • 87
    • 84855925831 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 620-623: Supplemental Assay Method for Potency Testing Enterotoxigenic (K99, K 88, 987P, F41 Pilus) Escherichia coli Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 620-623: Supplemental Assay Method for Potency Testing Enterotoxigenic (K99, K 88, 987P, F41 Pilus) Escherichia coli Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 88
    • 84855925830 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 624: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar pomona Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 624: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar pomona Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 89
    • 84855933942 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 608: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar pomona Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.101. SAM 608: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar pomona Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2008)
  • 90
    • 84855933941 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 625: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar canicola Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 625: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar canicola Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 91
    • 84555198316 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:0447. Canine Leptospirosis Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
    • European Pharmacopoeia. Monograph 01/2008:0447. Canine Leptospirosis Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 92
    • 84855913990 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 609: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar canicola Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.103. SAM 609: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar canicola Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2008)
  • 93
    • 84855953217 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 626: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar grippotyphosa Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 626: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar grippotyphosa Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 94
    • 84855953216 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 617: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar grippotyphosa Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.104. SAM 617: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar grippotyphosa Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2008)
  • 95
    • 84855953218 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 627: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 627: Supplemental Assay Method for in vitro Potency testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2009)
  • 96
    • 84855933943 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 610: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.102. SAM 610: Supplemental Assay Method for Potency Assay of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
    • (2008)
  • 97
    • 84555172447 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.105. Leptospira hardjo bacterin.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.105. Leptospira hardjo bacterin. 2002.
    • (2002)
  • 98
    • 84555193322 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:1939. Bovine Leptospirosis Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
    • European Pharmacopoeia. Monograph 01/2008:1939. Bovine Leptospirosis Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 99
    • 63849201560 scopus 로고    scopus 로고
    • Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement
    • Hendriksen C. Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev Vaccines 2008, 8(3):313-322.
    • (2008) Expert Rev Vaccines , vol.8 , Issue.3 , pp. 313-322
    • Hendriksen, C.1
  • 100
    • 84555193323 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.104. In vitro serial release potency test for completed product containing Clostridium chauvoei.
    • United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.104. In vitro serial release potency test for completed product containing Clostridium chauvoei. 2003.
    • (2003)
  • 101
    • 84555198307 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 220. Not available.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 220. Not available.
  • 102
    • 84555198314 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:0361. Clostridium chauvoei vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
    • European Pharmacopoeia. Monograph 01/2008:0361. Clostridium chauvoei vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 103
    • 84855953214 scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 120: Supplemental Assay Method for the in vitro Potency Assay of Bovine Respiratory Viruses in Killed Vaccines.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 120: Supplemental Assay Method for the in vitro Potency Assay of Bovine Respiratory Viruses in Killed Vaccines. 1991. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_100_series.shtml.
    • (1991)
  • 104
    • 84855953215 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 321: Supplemental Assay Method for Quantitating the GP70 Antigen of Feline Leukemia Virus Veterinary Vaccines.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 321: Supplemental Assay Method for Quantitating the GP70 Antigen of Feline Leukemia Virus Veterinary Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 105
    • 0026332164 scopus 로고
    • United States Department of Agriculture licensing requirements for feline leukemia virus vaccines
    • Shibley G.P., Tanner J.E., Hanna S.A. United States Department of Agriculture licensing requirements for feline leukemia virus vaccines. JAVMA 1991, 199:1402-1406.
    • (1991) JAVMA , vol.199 , pp. 1402-1406
    • Shibley, G.P.1    Tanner, J.E.2    Hanna, S.A.3
  • 106
    • 84855913988 scopus 로고    scopus 로고
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 322: Supplemental Assay Method for Determination of the Specific Viral Antigen Content in Inactivated Canine Coronavirus Vaccines.
    • United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 322: Supplemental Assay Method for Determination of the Specific Viral Antigen Content in Inactivated Canine Coronavirus Vaccines. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
    • (2007)
  • 107
    • 84555193321 scopus 로고    scopus 로고
    • European Pharmacopoeia. Monograph 01/2008:0870. Newcastle Disease Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
    • European Pharmacopoeia. Monograph 01/2008:0870. Newcastle Disease Vaccine (Inactivated). 5th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
    • (2008)
  • 108
    • 64949104542 scopus 로고    scopus 로고
    • Three Rs achievements in vaccinology. AATEX Special Issue
    • Hendriksen C. Three Rs achievements in vaccinology. AATEX Special Issue 2007;14:575-579.
    • (2007) , vol.14 , pp. 575-579
    • Hendriksen, C.1
  • 109
    • 17944364399 scopus 로고    scopus 로고
    • Validation study to evaluate the reproducibility of a candidate in vitro potency assay of Newcastle disease vaccines and to establish the suitability of a candidate biological reference preparation
    • Claassen I., Maas R., Oei H., Daas A., Milne C. Validation study to evaluate the reproducibility of a candidate in vitro potency assay of Newcastle disease vaccines and to establish the suitability of a candidate biological reference preparation. Pharmeuropa Bio 2004, 1:1-15.
    • (2004) Pharmeuropa Bio , vol.1 , pp. 1-15
    • Claassen, I.1    Maas, R.2    Oei, H.3    Daas, A.4    Milne, C.5
  • 110
    • 84555198311 scopus 로고    scopus 로고
    • EDQM International Symposium on Alternatives to animal testing new approaches in the development and control of biologicals, Dubrovnik, Croatia, 23-24 April
    • EDQM International Symposium on Alternatives to animal testing new approaches in the development and control of biologicals, Dubrovnik, Croatia, 23-24 April 2008.
    • (2008)
  • 111
    • 84555198313 scopus 로고    scopus 로고
    • Symposium, Practical Alternatives to Reduce Animal Testing in Quality Control of Veterinary Biologicals in the Americas, Buenos Aires, Argentina, February
    • Symposium, Practical Alternatives to Reduce Animal Testing in Quality Control of Veterinary Biologicals in the Americas, Buenos Aires, Argentina, February, 2010.
    • (2010)


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