-
1
-
-
84855981850
-
-
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
-
-
84555172398
-
-
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
-
3
-
-
84555217967
-
Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions.
-
McFarland R, Verthelyi D, Casey W, Arciniega J, Isbrucker R, Schmitt M, Finn T, Descamps J, Horiuchi Y, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
McFarland, R.1
Verthelyi, D.2
Casey, W.3
Arciniega, J.4
Isbrucker, R.5
Schmitt, M.6
Finn, T.7
Descamps, J.8
Horiuchi, Y.9
Sesardic, D.10
Stickings, P.11
Johnson, N.W.12
Lipscomb, E.13
Allen, D.14
-
4
-
-
84555196697
-
Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions.
-
Kulpa-Eddy J, Srinivas G, Halder M, Hill R, Brown K, Roth J, Draayer H, Galvin J, Claassen I, Gifford G, WoodlandR, Doelling V, Jones B, Stokes WS. Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Kulpa-Eddy, J.1
Srinivas, G.2
Halder, M.3
Hill, R.4
Brown, K.5
Roth, J.6
Draayer, H.7
Galvin, J.8
Claassen, I.9
Gifford, G.10
Woodland, R.11
Doelling, V.12
Jones, B.13
Stokes, W.S.14
-
5
-
-
84555196704
-
Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions.
-
Casey W, Schmitt M, McFarland R, Isbrucker R, Levis R, Arciniega J, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Casey, W.1
Schmitt, M.2
McFarland, R.3
Isbrucker, R.4
Levis, R.5
Arciniega, J.6
Descamps, J.7
Finn, T.8
Hendriksen, C.9
Horiuchi, Y.10
Keller, J.11
Kojima, H.12
Sesardic, D.13
Stickings, P.14
Johnson, N.W.15
Lipscomb, E.16
Allen, D.17
-
6
-
-
84555196698
-
Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions.
-
Stokes WS, Brown K, Kulpa-Eddy J, Srinivas G, Halder M, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B. Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Stokes, W.S.1
Brown, K.2
Kulpa-Eddy, J.3
Srinivas, G.4
Halder, M.5
Draayer, H.6
Galvin, J.7
Claassen, I.8
Gifford, G.9
Woodland, R.10
Doelling, V.11
Jones, B.12
-
7
-
-
84555191840
-
Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions.
-
Isbrucker R, Levis R, Casey W, McFarland R, Schmitt M, Arciniega J, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Allen D. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Isbrucker, R.1
Levis, R.2
Casey, W.3
McFarland, R.4
Schmitt, M.5
Arciniega, J.6
Descamps, J.7
Finn, T.8
Hendriksen, C.9
Horiuchi, Y.10
Keller, J.11
Kojima, H.12
Sesardic, D.13
Stickings, P.14
Johnson, N.W.15
Allen, D.16
-
8
-
-
84555190338
-
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.
-
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)
Proc Vaccinol (current issue)
-
-
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
-
Veterinary vaccines and their importance to animal health and public health.
-
Roth J. Veterinary vaccines and their importance to animal health and public health. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Roth, J.1
-
10
-
-
84555190332
-
Human vaccines and their importance to public health.
-
Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Schuchat, A.1
-
11
-
-
84555190330
-
FDA Requirements for human vaccine safety and potency testing.
-
Finn T. U.S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Finn, T.U.S.1
-
12
-
-
84555193290
-
USDA requirements for veterinary vaccine safety and potency testing.
-
Hill RE. USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Hill, R.E.1
-
14
-
-
84555217945
-
European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use.
-
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)
Proc Vaccinol (current issue)
-
-
Woodland, R.1
-
15
-
-
84555196676
-
Strategic approaches for developing alternative tests for safety and potency of vaccines.
-
Horiuchi Y, Ochiai M, Kataoka M, Yamamoto A, Yuen C-T, Asokanathan C, Corbel M, Kurata T, Xing D. Strategic approaches for developing alternative tests for safety and potency of vaccines. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Horiuchi, Y.1
Ochiai, M.2
Kataoka, M.3
Yamamoto, A.4
Yuen, C.-T.5
Asokanathan, C.6
Corbel, M.7
Kurata, T.8
Xing, D.9
-
17
-
-
84555190324
-
Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use.
-
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)
Proc Vaccinol (current issue)
-
-
Draayer, H.1
-
18
-
-
84555217940
-
Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency.
-
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)
Proc Vaccinol (current issue)
-
-
Claassen, I.1
-
19
-
-
84855981859
-
-
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
-
-
84555190321
-
A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency.
-
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)
Proc Vaccinol (current issue)
-
-
Descamps, J.1
-
21
-
-
84555196668
-
Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing.
-
Keller JE. Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol (current issue)
-
-
Keller, J.E.1
-
22
-
-
84855915728
-
-
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
-
Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines.
-
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)
Proc Vaccinol (current issue)
-
-
Stickings, P.1
Rigsby, P.2
Coombes, L.3
Hockley, J.4
Tierney, R.5
Sesardic, D.6
-
24
-
-
84555217934
-
Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine.
-
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)
Proc Vaccinol (current issue)
-
-
Arciniega, J.L.1
Domínguez-Castillo, R.I.2
-
26
-
-
84555191809
-
Examples of approaches to reducing animal numbers in vaccine potency testing
-
(current issue)
-
Kulpa-Eddy J, Srinivas G. Examples of approaches to reducing animal numbers in vaccine potency testing. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol.
-
-
Kulpa-Eddy, J.1
Srinivas, G.2
-
27
-
-
84555190317
-
Application of the consistency approach in the United States to reduce animal use in vaccine potency testing
-
(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)
Proc Vaccinol.
-
-
Kulpa-Eddy, J.1
Dusek, D.2
-
28
-
-
84555217925
-
Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives
-
(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)
Proc Vaccinol.
-
-
Gifford, G.1
Agrawal, P.2
Hutchings, D.3
Yarosh, O.4
-
29
-
-
84555190312
-
Target alternative vaccine safety testing strategies for Pertussis toxin
-
(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)
Proc Vaccinol
-
-
Arciniega, J.L.1
Corvette, L.2
Hsu, H.3
Lynn, F.4
Romani, T.5
Dobbelaer, R.6
-
30
-
-
84555191800
-
Toward replacement of the monkey neurovirulence test in vaccine safety testing
-
(current issue)
-
Rubin SA. Toward replacement of the monkey neurovirulence test in vaccine safety testing. Proc Vaccinol 2011 (current issue).
-
(2011)
Proc Vaccinol.
-
-
Rubin, S.A.1
-
31
-
-
84855940069
-
-
United States Public Law 430 of 1913 and Public Law 99-198 (1985 amendments to the Virus-Serum-Toxin Act); Title 21 U.S. Code, Chapter 5 §§ 151 et. seq
-
United States Public Law 430 of 1913 and Public Law 99-198 (1985 amendments to the Virus-Serum-Toxin Act); Title 21 U.S. Code, Chapter 5 §§ 151 et. seq.
-
-
-
-
32
-
-
84855915726
-
-
United States Department of Agriculture, Center for Veterinary Biologics Notice 04-09: Use of Humane Endpoints in Animal Testing of Biological Products. Available at:
-
United States Department of Agriculture, Center for Veterinary Biologics Notice 04-09: Use of Humane Endpoints in Animal Testing of Biological Products. 2004. Available at: http://www.aphis.usda.gov/animal_health/vet_biologics/vb_notices_2004.shtml.
-
(2004)
-
-
-
33
-
-
13844279157
-
The European Pharmacopoeia and humane endpoints
-
In: Hendriksen CFM, Morton DB, editors. Humane Endpoints in Animal Experiments for Biomedical Research. London, Royal Society of Medicine Press
-
Castle P. The European Pharmacopoeia and humane endpoints. In: Hendriksen CFM, Morton DB, editors. Humane Endpoints in Animal Experiments for Biomedical Research. London, Royal Society of Medicine Press, 1999:15-19.
-
(1999)
, pp. 15-19
-
-
Castle, P.1
-
34
-
-
0003060484
-
Reducing unrelieved pain and distress in laboratory animals using humane endpoints
-
Stokes, WS. Reducing unrelieved pain and distress in laboratory animals using humane endpoints. ILAR Journal 2000;41(2):59-61.
-
(2000)
ILAR Journal
, vol.41
, Issue.2
, pp. 59-61
-
-
Stokes, W.S.1
-
35
-
-
0036053309
-
Humane endpoints for laboratory animals used in regulatory testing
-
Stokes, WS. Humane endpoints for laboratory animals used in regulatory testing. ILAR Journal 2002; 43(Suppl):S31-S38.
-
(2002)
ILAR Journal.
, vol.43
, Issue.SUPPL.
-
-
Stokes, W.S.1
-
36
-
-
84555172396
-
-
OLAW/ARENA (Office of Laboratory Animal Welfare/Applied Research Ethics National Association). Institutional Animal Care and Use Committee Guidebook. 2nd ed. Bethesda: National Institutes of Health;
-
OLAW/ARENA (Office of Laboratory Animal Welfare/Applied Research Ethics National Association). Institutional Animal Care and Use Committee Guidebook. 2nd ed. Bethesda: National Institutes of Health; 2002.
-
(2002)
-
-
-
37
-
-
79251482684
-
United States Animal Welfare Act. Transportation, sale, and handling of certain animals
-
Title 7. U.S. Code, Chapter 54 §
-
United States Animal Welfare Act. Transportation, sale, and handling of certain animals. Title 7. U.S. Code, Chapter 54 § 2131-2159.
-
-
-
-
38
-
-
0001748577
-
European Union - Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
-
18/12/1986. Available at: in, press.
-
European Union - Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal L 358, 1-28; 18/12/1986. Available at: http://eur-x.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX: 31986L0609:EN: HTM.L., in, press.,.
-
Official Journal
, Issue.L 358
, pp. 1-28
-
-
-
39
-
-
79957595848
-
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
-
Available at:
-
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Official Journal of the European Union Official Journal of the European Union, L276; 33-79. Available at:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L: 2010:276:0033:0079:EN:PDF.
-
Official Journal of the European Union Official Journal of the European Union
, Issue.L276
, pp. 33-79
-
-
-
40
-
-
84855925411
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 117- Standard Requirements. Section 117.4e. Test Animals.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 117- Standard Requirements. Section 117.4e. Test Animals. http://law.justia.com/us/cfr/title09/9-1.0.1.5.54.html#9:1.0.1.5.54.0.77.4.
-
-
-
-
41
-
-
84555173500
-
-
European Pharmacopoeia. Monograph 01/2008:0062. Vaccines for Veterinary Use, Ph.Eur. 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2008:0062. Vaccines for Veterinary Use, Ph.Eur. 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
-
(2010)
-
-
-
42
-
-
0034573475
-
Refinement of vaccine potency testing with the use of humane endpoints
-
Hendriksen C, Steen B. Refinement of vaccine potency testing with the use of humane endpoints. ILAR Journal 2000;41(2):105-113.
-
(2000)
ILAR Journal
, vol.41
, Issue.2
, pp. 105-113
-
-
Hendriksen, C.1
Steen, B.2
-
43
-
-
84555198241
-
Center for Veterinary Biologics Notice No. 04-09: Use of Humane Endpoints in Animal Testing of Biological Products
-
Title 9 Code of Federal Regulations (9CFR)(e)
-
Center for Veterinary Biologics Notice No. 04-09: Use of Humane Endpoints in Animal Testing of Biological Products. 2004. Title 9 Code of Federal Regulations (9CFR) Part 116.4(e).
-
(2004)
, vol.4
, Issue.PART 116
-
-
-
44
-
-
84855915723
-
-
Canadian Council on Animal Care (CCAC). CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing. Ottawa, Canada
-
Canadian Council on Animal Care (CCAC). CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing. Ottawa, Canada, 1998 (http://ccac.ca/en_/standards/guidelines).
-
(1998)
-
-
-
45
-
-
33646464984
-
Harmonization of Animal Care and Use Guidance
-
Demers G, Griffin G, De Vroey G, Haywood JR, Zurlo J, Bedard M. Harmonization of Animal Care and Use Guidance. Science 2006;312: 700-701.
-
(2006)
Science.
, vol.312
, pp. 700-701
-
-
Demers, G.1
Griffin, G.2
De Vroey, G.3
Haywood, J.R.4
Zurlo, J.5
Bedard, M.6
-
46
-
-
63849201560
-
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
-
47
-
-
84855942490
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.209. SAM 308: Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccines in Mice Using the National Institutes of Health Test.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.209. SAM 308: Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccines in Mice Using the National Institutes of Health Test. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
-
(2007)
-
-
-
48
-
-
84555172395
-
-
European Pharmacopoeia. Monograph 01/2010:0451. Rabies Vaccine (Inactivated) for Veterinary Use. 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2010:0451. Rabies Vaccine (Inactivated) for Veterinary Use. 7th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
-
(2010)
-
-
-
49
-
-
0008466677
-
Humane endpoints for the estimation of lethality rates in the potency testing of rabies vaccines
-
Cussler K, DB Morton, C Hendriksen. Humane endpoints for the estimation of lethality rates in the potency testing of rabies vaccines. Alternativen zu Tierexperimenten 1998;15 Suppl:40-42.
-
(1998)
Alternativen zu Tierexperimenten
, vol.15
, Issue.SUPPL.
, pp. 40-42
-
-
Cussler, K.1
Morton, D.B.2
Hendriksen, C.3
-
50
-
-
84555198245
-
-
European Pharmacopoeia. Monograph 04/2008:0216. Rabies Vaccine for Human Use Prepared in Cell Culture. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 04/2008:0216. Rabies Vaccine for Human Use Prepared in Cell Culture. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
51
-
-
84855925411
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113 - Standard Requirements, Section 113.6. Animal and Plant Health Inspection Service Testing.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products, Part 113 - Standard Requirements, Section 113.6. Animal and Plant Health Inspection Service Testing. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
-
-
-
-
52
-
-
0038167608
-
Humane endpoints in the efficacy testing of swine erysipelas vaccines
-
Johannes S, Hartinger J, Hendriksen CFM, Morton DB, Cussler K. Humane endpoints in the efficacy testing of swine erysipelas vaccines. ALTEX 2003;20:11-15.
-
(2003)
ALTEX.
, vol.20
, pp. 11-15
-
-
Johannes, S.1
Hartinger, J.2
Hendriksen, C.F.M.3
Morton, D.B.4
Cussler, K.5
-
53
-
-
84855925411
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113 - Standard Requirements, Section 113.3. Sampling of Biological Products.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products, Part 113 - Standard Requirements, Section 113.3. Sampling of Biological Products. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
-
-
-
-
54
-
-
0142137146
-
Three Rs approaches in the quality control of inactivated rabies vaccines
-
The report and recommendations of ECVAM Workshop 48. ALTA
-
Bruckner L, Cussler K, Halder M, Barrat J, Castle P, Duchow K, Gatewood DM, Gibert R, Groen J, Knapp B, Levis R, Milne C, Parker S, Stünkel K, Visser N, Volkers P. Three Rs approaches in the quality control of inactivated rabies vaccines. The report and recommendations of ECVAM Workshop 48. ALTA 2003;31:429-454.
-
(2003)
, vol.31
, pp. 429-454
-
-
Bruckner, L.1
Cussler, K.2
Halder, M.3
Barrat, J.4
Castle, P.5
Duchow, K.6
Gatewood, D.M.7
Gibert, R.8
Groen, J.9
Knapp, B.10
Levis, R.11
Milne, C.12
Parker, S.13
Stünkel, K.14
Visser, N.15
Volkers, P.16
-
55
-
-
33846336748
-
The rabies peripheral challenge test: more accurate determination of vaccine potency
-
Wunderli PS, Dreesen DW, Miller TJ, Baer GM. The rabies peripheral challenge test: more accurate determination of vaccine potency. Vaccine 2006;24:7115-7123.
-
(2006)
Vaccine.
, vol.24
, pp. 7115-7123
-
-
Wunderli, P.S.1
Dreesen, D.W.2
Miller, T.J.3
Baer, G.M.4
-
56
-
-
84855940067
-
-
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. Erysipelothrix Rhusiopathiae Vaccine.
-
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. Erysipelothrix Rhusiopathiae Vaccine. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
-
-
-
-
57
-
-
84855925411
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113 - Standard Requirements, Section 113.326. Avian Pox Vaccineccine.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products, Part 113 - Standard Requirements, Section 113.326. Avian Pox Vaccineccine. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
-
-
-
-
58
-
-
84555173480
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.106. SAM 200: Supplemental Assay Method for Potency Testing Products Containing Clostridium chauvoei Antigen.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.106. SAM 200: Supplemental Assay Method for Potency Testing Products Containing Clostridium chauvoei Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2008)
-
-
-
59
-
-
84555173480
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.107. SAM 209: Supplemental Assay Method for Potency Testing Products Containing Clostridium haemolyticum Antigen.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.107. SAM 209: Supplemental Assay Method for Potency Testing Products Containing Clostridium haemolyticum Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2008)
-
-
-
60
-
-
84555198231
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.110. SAM 213: Supplemental Assay Method for Potency Testing of Clostridium botulinum Type C Bacterin-Toxoids.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.110. SAM 213: Supplemental Assay Method for Potency Testing of Clostridium botulinum Type C Bacterin-Toxoids. 2009.
-
(2009)
-
-
-
61
-
-
84555173480
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.111. SAM 201: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type C Beta Antigen.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.111. SAM 201: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type C Beta Antigen. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2008)
-
-
-
62
-
-
84855942490
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.112. SAM 203: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type D Epsilon Antigen.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.112. SAM 203: Supplemental Assay Method for Potency Testing of Clostridium perfringens Type D Epsilon Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2007)
-
-
-
63
-
-
84855940068
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.108. SAM 207: Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.108. SAM 207: Supplemental Assay Method for Potency Testing Clostridium novyi Type B Alpha Antigen. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2007)
-
-
-
64
-
-
84555172383
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products
-
Part 113- Standard Requirements. Section 113.109. SAM 212: Supplemental Assay Method for Potency Testing of Clostridium sordellii Antigen
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.109. SAM 212: Supplemental Assay Method for Potency Testing of Clostridium sordellii Antigen. 2010.
-
(2010)
-
-
-
65
-
-
84555193223
-
Alternatives to animal challenge tests in the batch control of Leptospira vaccines for veterinary use. Pharmeuropa Special Issue
-
(eds).Strasbourg: Council of Europe, EDQM; Bio
-
Castle P, Coune C, Ellis W, Esposito-Farese M-E, Spieser J-M, LeTarnec C, (eds). Alternatives to animal challenge tests in the batch control of Leptospira vaccines for veterinary use. Pharmeuropa Special Issue. Strasbourg: Council of Europe, EDQM; 1999;Bio 99-102.
-
(1999)
, pp. 99-102
-
-
Castle, P.1
Coune, C.2
Ellis, W.3
Esposito-Farese, M.-E.4
Spieser, J.-M.5
LeTarnec, C.6
-
66
-
-
84884138067
-
Guinea pig serology as an alternative to the hamster challenge test for potency testing of Leptospira hardjo vaccines. Pharmeuropa
-
Ebert E. Guinea pig serology as an alternative to the hamster challenge test for potency testing of Leptospira hardjo vaccines. Pharmeuropa 1999;102-110.
-
(1999)
, pp. 102-110
-
-
Ebert, E.1
-
67
-
-
84555173480
-
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.
-
(2008)
-
-
-
68
-
-
84555173496
-
-
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.
-
(2008)
-
-
-
69
-
-
84555172391
-
-
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.
-
(2008)
-
-
-
70
-
-
84555173486
-
-
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.
-
(2008)
-
-
-
71
-
-
84555198218
-
-
European Pharmacopoeia. Monograph 01/2008:0064. Swine Erysipelas Vaccine (Inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2008:0064. Swine Erysipelas Vaccine (Inactivated). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
72
-
-
84855968477
-
-
United States Department of Agriculture, Center for Veterinary Biologics, SAM 217: Supplemental Assay Method for Potency Testing Tetanus Toxoid by ELISA.
-
United States Department of Agriculture, Center for Veterinary Biologics, SAM 217: Supplemental Assay Method for Potency Testing Tetanus Toxoid by ELISA. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2009)
-
-
-
73
-
-
84555198219
-
-
European Pharmacopoeia. Monograph 01/2008:0697. Tetanus Vaccine for Veterinary Use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2008:0697. Tetanus Vaccine for Veterinary Use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
74
-
-
84555193247
-
-
European Pharmacopoeia. Monograph 01/2008:0363. Clostridium perfringens vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2008:0363. Clostridium perfringens vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
75
-
-
84555193248
-
-
European Pharmacopoeia. Monograph 01/2008:0364. Clostridium septicum vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2008:0364. Clostridium septicum vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
76
-
-
84555172384
-
-
European Pharmacopoeia. Monograph 01/2010:0362. Clostridium novyi (type B) vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe
-
European Pharmacopoeia. Monograph 01/2010:0362. Clostridium novyi (type B) vaccine for veterinary use. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2010.
-
(2010)
-
-
-
77
-
-
64949104542
-
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
-
78
-
-
84555198239
-
-
European Pharmacopoeia. Monograph 01/2008:0447. Canine Leptospirosis vaccine (inactivated). 6th 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). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
79
-
-
84555173497
-
-
European Pharmacopoeia. Monograph 01/2008:1939. Bovine leptospirosis vaccine (inactivated). 6th 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). 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
80
-
-
79952475204
-
Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use
-
Kramer B, Bruckner L, Daas A, Milne C. Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use. Pharmeuropa Bio 2010;37-55.
-
(2010)
Pharmeuropa Bio.
, pp. 37-55
-
-
Kramer, B.1
Bruckner, L.2
Daas, A.3
Milne, C.4
-
81
-
-
63249116538
-
The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines
-
Kramer B, Schildger H, Behrensdorf-Nicol HA, Hanschmann KM, Duchow K. The rapid fluorescent focus inhibition test is a suitable method for batch potency testing of inactivated rabies vaccines. Biologicals 2009;37(2):119-126.
-
(2009)
Biologicals.
, vol.37
, Issue.2
, pp. 119-126
-
-
Kramer, B.1
Schildger, H.2
Behrensdorf-Nicol, H.A.3
Hanschmann, K.M.4
Duchow, K.5
-
82
-
-
0032029478
-
Development of a florescent antibody virus neutralization test (FAVN test) for the quantitation of rabies-neutralising antibody
-
Cliquet F, Aubert M, Sange L. Development of a florescent antibody virus neutralization test (FAVN test) for the quantitation of rabies-neutralising antibody. Journal of Immunological Methods 1998;212:79-87.
-
(1998)
Journal of Immunological Methods.
, vol.212
, pp. 79-87
-
-
Cliquet, F.1
Aubert, M.2
Sange, L.3
-
83
-
-
33644513392
-
A simple immuno-capture ELISA to estimate rabies viral glycoprotein antigen in vaccine manufacture
-
Nagarajan T, Reddy GS, Mohana Subramanian B, Rajalakshmi S, Thiagarajan D, Tordo N, Jallet C, Srinivasan VA. A simple immuno-capture ELISA to estimate rabies viral glycoprotein antigen in vaccine manufacture. Biologicals 2006;34:21-27.
-
(2006)
Biologicals.
, vol.34
, pp. 21-27
-
-
Nagarajan, T.1
Reddy, G.S.2
Mohana Subramanian, B.3
Rajalakshmi, S.4
Thiagarajan, D.5
Tordo, N.6
Jallet, C.7
Srinivasan, V.A.8
-
84
-
-
84855968473
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 315: Supplemental Assay Method for the Detection of Serum Neutralizing Antibodies to Rabies Virus Using the Rapid Fluorescent Focus Inhibition Test (RFFIT).
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. SAM 315: Supplemental Assay Method for the Detection of Serum Neutralizing Antibodies to Rabies Virus Using the Rapid Fluorescent Focus Inhibition Test (RFFIT). 2011. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_300_series.shtml.
-
(2011)
-
-
-
85
-
-
84555193250
-
-
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
-
-
-
86
-
-
0035825058
-
Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test
-
Rosskopf-Streicher U, Johannes S, Wilhelm M, Cussler K. Quality control of inactivated erysipelas vaccines: results of an international collaborative study to establish a new regulatory test. Vaccine 2001;19:1477-1483.
-
(2001)
Vaccine.
, vol.19
, pp. 1477-1483
-
-
Rosskopf-Streicher, U.1
Johannes, S.2
Wilhelm, M.3
Cussler, K.4
-
87
-
-
0001877807
-
Wirksamkeitsprüfung von Rotlaufimpfstoffen an der Labormaus. ELISA kontra Infektionsversuch
-
Beckmann R, Cussler K. Wirksamkeitsprüfung von Rotlaufimpfstoffen an der Labormaus. ELISA kontra Infektionsversuch. ALTEX (Suppl) 1994;1:39-45.
-
(1994)
ALTEX.
, vol.1
, Issue.SUPPL.
, pp. 39-45
-
-
Beckmann, R.1
Cussler, K.2
-
88
-
-
84855915722
-
-
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. 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. 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)
-
-
-
89
-
-
84855968478
-
-
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. 2009. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_600_series.shtml.
-
(2009)
-
-
-
90
-
-
2542635812
-
Validation of alternative methods for the potency testing of vaccines: the report and recommendations of ECVAM workshop 31
-
Hendriksen C, Spieser JM, Akkermans A, Balls M, Bruckner L, Cussler K, Daas A, Descamps J, Dobbelaer R, Fentem J, Halder M, van der Kamp M, Lucken R, Milstien J, Sesardic D, Straughan D, Valadares A. Validation of alternative methods for the potency testing of vaccines: the report and recommendations of ECVAM workshop 31. ALTA 1998;26:747-761.
-
(1998)
ALTA.
, vol.26
, pp. 747-761
-
-
Hendriksen, C.1
Spieser, J.M.2
Akkermans, A.3
Balls, M.4
Bruckner, L.5
Cussler, K.6
Daas, A.7
Descamps, J.8
Dobbelaer, R.9
Fentem, J.10
Halder, M.11
van der Kamp, M.12
Lucken, R.13
Milstien, J.14
Sesardic, D.15
Straughan, D.16
Valadares, A.17
-
91
-
-
84555193277
-
EDQM. Alternative potency testing and other possible related quality issues for veterinary clostridial vaccines
-
Pharmeuropa, 1997 Special Issue, Bio 97-1. Strasbourg, France: European Department for the Quality of Medicines
-
EDQM. Alternative potency testing and other possible related quality issues for veterinary clostridial vaccines. Pharmeuropa, 1997 Special Issue, Bio 97-1. Strasbourg, France: European Department for the Quality of Medicines.
-
-
-
-
92
-
-
3242742954
-
Quality assurance of C. perfringens epsilon toxoid vaccines- ELISA versus mouse neutralisation test
-
Rosskopf-Streicher U, Volkers P, Noeske K, Werner, E. Quality assurance of C. perfringens epsilon toxoid vaccines- ELISA versus mouse neutralisation test. Alternativen zu Tierexperimenten 2004; 21(Suppl.):65-69.
-
(2004)
Alternativen zu Tierexperimenten.
, vol.21
, Issue.SUPPL.
, pp. 65-69
-
-
Rosskopf-Streicher, U.1
Volkers, P.2
Noeske, K.3
Werner, E.4
-
93
-
-
0027992359
-
Interlaboratory validation of the in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use
-
Hendriksen C, Woltjes J, Akkermans AM, van der Gun JW, Marsman FR, Verschure MH, Veldman K. Interlaboratory validation of the in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals 1994;22:257-268.
-
(1994)
Biologicals.
, vol.22
, pp. 257-268
-
-
Hendriksen, C.1
Woltjes, J.2
Akkermans, A.M.3
van der Gun, J.W.4
Marsman, F.R.5
Verschure, M.H.6
Veldman, K.7
-
94
-
-
84555193258
-
-
Council of Europe. 2.7.8 Assay of Tetanus vaccine (adsorbed). European Pharmacopoeia. Strasbourg, France: Council of Europe
-
Council of Europe. 2.7.8 Assay of Tetanus vaccine (adsorbed). European Pharmacopoeia. 1996. Strasbourg, France: Council of Europe.
-
(1996)
-
-
-
95
-
-
84855968479
-
-
United States Department of Agriculture, Center for Veterinary Biologics, SAM 206: Supplemental Assay Method for Potency Testing Tetanus Antitoxins.
-
United States Department of Agriculture, Center for Veterinary Biologics, SAM 206: Supplemental Assay Method for Potency Testing Tetanus Antitoxins. 2007. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_sams_200_series.shtml.
-
(2007)
-
-
-
96
-
-
84855940065
-
-
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. http://www.access.gpo.gov/nara/cfr/waisidx_09/9cfr113_09.html.
-
-
-
-
97
-
-
84855915720
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.90. Guidelines for veterinary biological relative potency assays and reference preparations based on ELISA antigen quantification
-
United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.90. Guidelines for veterinary biological relative potency assays and reference preparations based on ELISA antigen quantification. 1998. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_vs_memos_2.shtml.
-
(1998)
-
-
-
98
-
-
84855933770
-
-
World Health Organization. Rabies vaccines: WHO Position paper. No 32
-
World Health Organization. Rabies vaccines: WHO Position paper. No 32, 2010, 85; 309-320. (http://www.who.int/wer).
-
(2010)
, vol.85
, pp. 309-320
-
-
-
99
-
-
0001271311
-
A rapid tissue culture test for determining rabies neutralising antibody
-
In: Meslin F-X, Kaplan MM, Hoprowski H, editors. Laboratory Techniques in Rabies. Geneva, Switzerland, World Trade Organization
-
Smith JS, Yager PA, Baer GM. A rapid tissue culture test for determining rabies neutralising antibody. In: Meslin F-X, Kaplan MM, Hoprowski H, editors. Laboratory Techniques in Rabies. Geneva, Switzerland, World Trade Organization 1996;4:354-357.
-
(1996)
, vol.4
, pp. 354-357
-
-
Smith, J.S.1
Yager, P.A.2
Baer, G.M.3
-
100
-
-
84855981854
-
-
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. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_vs_memos_3.shtml.
-
(2003)
-
-
-
101
-
-
84555193253
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.106. SAM 220: In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei.
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. Part 113- Standard Requirements. Section 113.106. SAM 220: In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei. 2003.
-
(2003)
-
-
-
102
-
-
84855981855
-
-
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)
-
-
-
103
-
-
84855940064
-
-
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)
-
-
-
104
-
-
84855981853
-
-
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)
-
-
-
105
-
-
84855915719
-
-
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)
-
-
-
106
-
-
38349193094
-
The consistency approach for the quality control of vaccines
-
Hendriksen C, Arciniega JL, Bruckner L, Chevalier M, Coppens E, Descamps J, Duchene M, Dusek DM, Halder M, Kreeftenberg H, Maes A, Redhead K, Ravetkar SD, Spieser J-M, Swam H. The consistency approach for the quality control of vaccines. Biologicals 2008;36:73-77.
-
(2008)
Biologicals.
, vol.36
, pp. 73-77
-
-
Hendriksen, C.1
Arciniega, J.L.2
Bruckner, L.3
Chevalier, M.4
Coppens, E.5
Descamps, J.6
Duchene, M.7
Dusek, D.M.8
Halder, M.9
Kreeftenberg, H.10
Maes, A.11
Redhead, K.12
Ravetkar, S.D.13
Spieser, J.-M.14
Swam, H.15
-
107
-
-
78650239124
-
Application of the Three Rs to challenge assays used in vaccine testing: Tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement
-
Jennings M, Morton D, Charton E, Cooper J, Hendriksen C, Martin S, Pearce M, Price S, Redhead K, Reed N, Simmons H, Spencer S, Willingale H. Application of the Three Rs to challenge assays used in vaccine testing: Tenth report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement. Biologicals 2010;38:684-695.
-
(2010)
Biologicals.
, vol.38
, pp. 684-695
-
-
Jennings, M.1
Morton, D.2
Charton, E.3
Cooper, J.4
Hendriksen, C.5
Martin, S.6
Pearce, M.7
Price, S.8
Redhead, K.9
Reed, N.10
Simmons, H.11
Spencer, S.12
Willingale, H.13
-
108
-
-
0030634560
-
Vitro methods for vaccine evaluation
-
Reitan LJ, Secombes CJ. In vitro methods for vaccine evaluation. Dev Biol Stand 1997; 90:293-301.
-
(1997)
Dev Biol Stand.
, vol.90
, pp. 293-301
-
-
Reitan, L.J.1
Secombes, C.J.2
-
109
-
-
0035452023
-
Aquaculture pharmaceuticals and biologicals: current perspectives and future possibilities
-
Shao Z. Aquaculture pharmaceuticals and biologicals: current perspectives and future possibilities. Advanced Drug Delivery Reviews 2001;50:229-243.
-
(2001)
Advanced Drug Delivery Reviews.
, vol.50
, pp. 229-243
-
-
Shao, Z.1
-
110
-
-
0030630917
-
Adjuvants and immunostimulants for enhancing vaccine potency in fish
-
Anderson DP. Adjuvants and immunostimulants for enhancing vaccine potency in fish. Salmon Bay Biologicals 1997;90:257-265.
-
(1997)
Salmon Bay Biologicals.
, vol.90
, pp. 257-265
-
-
Anderson, D.P.1
-
111
-
-
0022924278
-
Reduction in animal usage for potency testing of diphtheria and tetanus toxoids
-
Stainer DW, Jakus CM, Sparkus JD. Reduction in animal usage for potency testing of diphtheria and tetanus toxoids. Develop Biol Stand 1986;65:241-244.
-
(1986)
Develop Biol Stand.
, vol.65
, pp. 241-244
-
-
Stainer, D.W.1
Jakus, C.M.2
Sparkus, J.D.3
-
112
-
-
0022924283
-
Studies on the minimal number of animals required to achieve assurance of satisfactory potency in diphtheria and tetanus vaccines
-
Knight PA, Roberts PAG. Studies on the minimal number of animals required to achieve assurance of satisfactory potency in diphtheria and tetanus vaccines. Develop Biol Stand 1986;65:245-255.
-
(1986)
Develop Biol Stand.
, vol.65
, pp. 245-255
-
-
Knight, P.A.1
Roberts, P.A.G.2
-
113
-
-
64949139667
-
Potency evaluation of rabies vaccine for human use: the impact of the reduction in the number of animals per dilution
-
Correa de Moura W, Pinheiro de Araujo H, Cabello P. Potency evaluation of rabies vaccine for human use: the impact of the reduction in the number of animals per dilution. Journal of Virological Methods 2009;158:84-92.
-
(2009)
Journal of Virological Methods
, vol.158
, pp. 84-92
-
-
Correa de Moura, W.1
Pinheiro de Araujo, H.2
Cabello, P.3
-
114
-
-
84855915717
-
-
World Organization for Animal Health (2010). Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 2.4.7. Pages 10-12.
-
World Organization for Animal Health (2010). Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2010. Volume 2, Chapter 2.4.7. Pages 10-12. http://www.oie.int/eng/normes/mmanual/2008/pdf/2.04.07_BOVINE_TB.pdf.
-
(2010)
, vol.1
-
-
-
115
-
-
0041549074
-
NIH test, a problematic method for testing potency of inactivated rabies vaccine
-
Barth R, Diderrich G, Weinmann E. NIH test, a problematic method for testing potency of inactivated rabies vaccine. Vaccine 1988;6:369-377.
-
(1988)
Vaccine.
, vol.6
, pp. 369-377
-
-
Barth, R.1
Diderrich, G.2
Weinmann, E.3
-
116
-
-
0037567721
-
Effects of vaccine route and dosage on protection from rabies after intracerebral challenge in mice
-
Wunderli PS, Dreesen DW, Miller TJ, Baer GM. Effects of vaccine route and dosage on protection from rabies after intracerebral challenge in mice. Am J Vet Med 2003;64:491-498.
-
(2003)
Am J Vet Med
, vol.64
, pp. 491-498
-
-
Wunderli, P.S.1
Dreesen, D.W.2
Miller, T.J.3
Baer, G.M.4
-
117
-
-
84855915718
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.112. Guidelines for validation of in vitro potency assays.
-
United States Department of Agriculture, Center for Veterinary Biologics, Veterinary Services Memorandum No. 800.112. Guidelines for validation of in vitro potency assays. 2008. http://www.aphis.usda.gov/animal_health/vet_biologics/vb_vs_memos_3.shtml.
-
(2008)
-
-
-
118
-
-
84855968475
-
-
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH): GL 41; TARGET ANIMAL SAFETY: EXAMINATION OF LIVE VETERINARY VACCINES IN TARGET ANIMALS FOR ABSENCE OF REVERSION TO VIRULENCE. Available at:
-
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH): GL 41; TARGET ANIMAL SAFETY: EXAMINATION OF LIVE VETERINARY VACCINES IN TARGET ANIMALS FOR ABSENCE OF REVERSION TO VIRULENCE. 2007. Available at: http://www.vichsec.org/en/guidelines2.htm.
-
(2007)
-
-
-
119
-
-
84855981852
-
-
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH): GL 44; Target Animal Safety for Veterinary Live and Inactivated vaccines. Available at:
-
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH): GL 44; Target Animal Safety for Veterinary Live and Inactivated vaccines. 2008. Available at: http://www.vichsec.org/en/guidelines2.htm.
-
-
-
|