-
1
-
-
84855978729
-
-
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
-
-
84555172441
-
-
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. Proc Vaccinol (current issue).
-
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)
-
-
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
-
Proc Vaccinol (current issue).
-
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)
-
-
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
-
Proc Vaccinol (current issue).
-
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)
-
-
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
-
Proc Vaccinol (current issue).
-
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)
-
-
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
-
Proc Vaccinol (current issue).
-
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)
-
-
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
-
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
-
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
-
Human vaccines and their importance to public health
-
Proc Vaccinol 2011 (current issue).
-
Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol 2011 (current issue).
-
-
-
Schuchat, A.1
-
11
-
-
84555190330
-
-
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
-
-
84555193312
-
-
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
-
-
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
-
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
-
15
-
-
84555196676
-
Strategic approaches for developing alternative tests for safety and potency of vaccines
-
Proc Vaccinol 2011 (current issue).
-
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).
-
-
-
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
-
16
-
-
84555196680
-
-
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
-
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
-
-
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
-
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
-
Proc Vaccinol (current issue).
-
Descamp 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)
-
-
Descamp, J.1
-
21
-
-
84555196668
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives
-
Proc Vaccinol (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
-
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
-
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
-
Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001
-
Arch Pediatr Adolesc Med
-
Zhou F, Santoli J, 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;159:1136-1144.
-
(2005)
, vol.159
, pp. 1136-1144
-
-
Zhou, F.1
Santoli, J.2
Messonnier, M.L.3
Yusuf, H.R.4
Shefer, A.5
Chu, S.Y.6
Rodewald, L.7
Harpaz, R.8
-
32
-
-
79551571017
-
-
The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs. Biologicals
-
De Mattia F, Chapsal J-M, Descamps J, Halder M, Jarrett N, Kross I, Mortiaux F, Ponsar C, Redhead K, McKelvie J, Hendriksen C. The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs. Biologicals 2011;39:59-65.
-
(2011)
, vol.39
, pp. 59-65
-
-
De Mattia, F.1
Chapsal, J.-M.2
Descamps, J.3
Halder, M.4
Jarrett, N.5
Kross, I.6
Mortiaux, F.7
Ponsar, C.8
Redhead, K.9
McKelvie, J.10
Hendriksen, C.11
-
33
-
-
84855948769
-
-
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)
-
-
-
34
-
-
84855929818
-
-
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)
-
-
-
35
-
-
84555198296
-
-
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)
-
-
-
36
-
-
4444325316
-
Use and validation of a single vaccine dilution assay for testing the potency of diphtheria, tetanus and combined vaccines. In: WHO Manual of laboratory methods: For testing of vaccines used in the WHO Expanded Programme on Immunization
-
Dobbelaer R, Knight P, Lyng J. Use and validation of a single vaccine dilution assay for testing the potency of diphtheria, tetanus and combined vaccines. In: WHO Manual of laboratory methods: For testing of vaccines used in the WHO Expanded Programme on Immunization. Geneva: World Health Organization, 1997:162-74.
-
(1997)
Geneva: World Health Organization
, pp. 162-174
-
-
Dobbelaer, R.1
Knight, P.2
Lyng, J.3
-
37
-
-
84555198297
-
-
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)
-
-
-
38
-
-
84555198273
-
-
World Health Organization. Recommendations for diphtheria, tetanus, pertussis and combined vaccines (Amendments 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, (WHO Technical Report Series No. 927).
-
World Health Organization. Recommendations for diphtheria, tetanus, pertussis and combined vaccines (Amendments 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, (WHO Technical Report Series No. 927).
-
(2005)
-
-
-
39
-
-
84555172437
-
-
United States Minimum Requirements: Tetanus toxoid
-
United States Minimum Requirements: Tetanus toxoid, 1952.
-
(1952)
-
-
-
40
-
-
84555173536
-
-
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
-
-
84555198299
-
-
United States Minimum Requirements: Diphtheria
-
United States Minimum Requirements: Diphtheria, 1947.
-
(1947)
-
-
-
42
-
-
84555193309
-
-
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
-
-
84555173515
-
-
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
-
-
0032457366
-
-
WHO guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. Biologicals
-
Arciniega JL, Corbel M, Dellepiane N, Dobbelaer R, Griffiths E, Heron I, et al. WHO guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. Biologicals 1998; 26(3):195-204.
-
(1998)
, vol.26
, Issue.3
, pp. 195-204
-
-
Arciniega, J.L.1
Corbel, M.2
Dellepiane, N.3
Dobbelaer, R.4
Griffiths, E.5
Heron, I.6
-
45
-
-
84555198293
-
-
European Pharmacopoeia. Monograph 20707. Assay of pertussis vaccine, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe.Ph Eur 2.7.7.
-
European Pharmacopoeia. Monograph 20707. Assay of pertussis vaccine, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.Ph Eur 2.7.7.
-
(2008)
-
-
-
46
-
-
84555173538
-
-
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)
-
-
-
47
-
-
84555198290
-
-
World Health Organization. Guidelines for the production and control of the acellular pertussis component 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. Guidelines for the production and control of the acellular pertussis component 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)
-
-
-
48
-
-
84555193305
-
-
European Pharmacopoeia. Monograph 216. Rabies vaccine for human use prepared in cell cultures Rabies 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 216. Rabies vaccine for human use prepared in cell cultures Rabies 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)
-
-
-
49
-
-
77955999328
-
World Health Organization. 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. 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)
-
-
-
50
-
-
84555172435
-
-
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
-
51
-
-
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
-
52
-
-
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
-
53
-
-
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
-
54
-
-
0034573475
-
Refinement of vaccine potency testing with the use of humane en3dpoints
-
Hendriksen C, Steen B. Refinement of vaccine potency testing with the use of humane en3dpoints. ILAR Journal 2000;41(2):105-113.
-
(2000)
ILAR Journal
, vol.41
, Issue.2
, pp. 105-113
-
-
Hendriksen, C.1
Steen, B.2
-
55
-
-
84555173537
-
-
European Pharmacopoeia. Monograph 01/2008:0062. Vaccines for Veterinary Use, Ph.Eur. 6th 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. 6th ed. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
56
-
-
84855947324
-
-
United States Department of Agriculture, Center for Veterinary Biologics, Code of Federal Regulations, Title 9, Animals and Animal Products. - 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.
-
, Issue.PART 117
-
-
-
57
-
-
84555173531
-
-
European Pharmacopoeia. Monograph 0153. Vaccines for human use, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe;
-
European Pharmacopoeia. Monograph 0153. Vaccines for human use, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
-
(2008)
-
-
-
58
-
-
84855947325
-
-
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.
-
-
-
-
59
-
-
84555193284
-
-
Council of Europe. European Convention for the Protection of Vertebrate Animals Used for Experimental and Scientific Purposes. 1986, European Treaty Series. Council of Europe. European Pharmacopoeia 3rd Edition.
-
Council of Europe. European Convention for the Protection of Vertebrate Animals Used for Experimental and Scientific Purposes. 1986, European Treaty Series. Council of Europe. European Pharmacopoeia 3rd Edition. 1997.
-
(1997)
-
-
-
60
-
-
33750709352
-
-
Towards eliminating the use of animals for regulatory required vaccine quality control. ALTEX
-
Hendriksen CFM. Towards eliminating the use of animals for regulatory required vaccine quality control. ALTEX 2006;23:187-190.
-
(2006)
, vol.23
, pp. 187-190
-
-
Hendriksen, C.F.M.1
-
61
-
-
0036053311
-
Refinement, reduction, and replacement of animal use for regulatory testing: current best scientific practices for the evaluation of safety and potency of biologicals
-
Hendriksen CFM. Refinement, reduction, and replacement of animal use for regulatory testing: current best scientific practices for the evaluation of safety and potency of biologicals. ILAR Journal 2002; 43: Supplement S43-S48.
-
(2002)
ILAR Journal
, vol.43
, Issue.SUPPL.
-
-
Hendriksen, C.F.M.1
-
62
-
-
0035221401
-
-
Clinical endpoints during rabies vaccine control tests. ALTEX
-
Hartinger J, Folz T, Cussler K. Clinical endpoints during rabies vaccine control tests. ALTEX 2000;18:37-40.
-
(2000)
, vol.18
, pp. 37-40
-
-
Hartinger, J.1
Folz, T.2
Cussler, K.3
-
63
-
-
0000784568
-
The evaluation of humane endpoints in pertussis vaccine potency testing
-
In: Hendriksen CFM, Morton DB, eds. Humane endpoints in animal experiments for biomedical research. London: The Royal Society Medicine Press
-
Hendriksen CFM, Steen B, Visser J, Cussler K, Morton D, Streijger F. The evaluation of humane endpoints in pertussis vaccine potency testing. In: Hendriksen CFM, Morton DB, eds. Humane endpoints in animal experiments for biomedical research. London: The Royal Society Medicine Press, 1999, p. 106-13.
-
(1999)
, pp. 106-113
-
-
Hendriksen, C.F.M.1
Steen, B.2
Visser, J.3
Cussler, K.4
Morton, D.5
Streijger, F.6
-
64
-
-
84555193307
-
-
Collaborative study for the validation of serological methods for potency testing of tetanus toxoid vaccines for human use - Pharmeuropa Bio
-
Collaborative study for the validation of serological methods for potency testing of tetanus toxoid vaccines for human use - part 1. Pharmeuropa Bio 2001;(2):1-92.
-
(2001)
, Issue.2 PART 1
, pp. 1-92
-
-
-
65
-
-
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
-
66
-
-
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
-
67
-
-
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
-
68
-
-
7944220094
-
Validation of an anti-PA-ELISA for the potency testing of anthrax vaccine in mice
-
Pombo M, Berthold I, Gingrich E, Jaramillo M, Leef M, Sirota L, Hsu H, Arciniega J. Validation of an anti-PA-ELISA for the potency testing of anthrax vaccine in mice. Biologicals 2004;32:157-163.
-
(2004)
Biologicals
, vol.32
, pp. 157-163
-
-
Pombo, M.1
Berthold, I.2
Gingrich, E.3
Jaramillo, M.4
Leef, M.5
Sirota, L.6
Hsu, H.7
Arciniega, J.8
-
70
-
-
84555198292
-
-
Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines -
-
Winsnes R, Sesardic D, Daas A, Behr-Gross M-E. Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines - Part 1.
-
, Issue.PART 1
-
-
Winsnes, R.1
Sesardic, D.2
Daas, A.3
Behr-Gross, M.-E.4
-
71
-
-
4644226722
-
Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines
-
Phase I and II. Pharmeuropa BIO 2003-2
-
Winsnes R, Sesardic D, Dass A, Behr-Gross M-E (2004). Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines. Phase I and II. Pharmeuropa BIO, 2003-2, 35-68.
-
(2004)
, pp. 35-68
-
-
Winsnes, R.1
Sesardic, D.2
Dass, A.3
Behr-Gross, M.-E.4
-
72
-
-
64949139667
-
Potency evaluation of rabies vaccine for human use: the impact of the reduction in the number of animals per dilution
-
de Moura WC, de Araujo HP, Cabello PH, Romijn PC, Leite JPG. Potency evaluation of rabies vaccine for human use: the impact of the reduction in the number of animals per dilution. J Virol Methods 2009;158:84-92.
-
(2009)
J Virol Methods
, vol.158
, pp. 84-92
-
-
de Moura, W.C.1
de Araujo, H.P.2
Cabello, P.H.3
Romijn, P.C.4
Leite, J.P.G.5
-
73
-
-
38349193094
-
The consistency approach for the quality control of vaccines
-
Hendriksen C, Arciniega JL, Bruckner L, Chevalier M, Coppens E, Descamps J, Duchêne M, Dusek DM, Halder M, Kreeftenberg H, Maes A, Redhead K, Ravetkar SD, Spieser JM, 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
Duchêne, 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
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