Laboratory animals in vaccine production and control: Replacement, reduction and refinement by C.F.M. HendriksenLaboratory animals in vaccine production and control: Replacement, reduction and refinement by C.F.M. Hendriksen

Laboratory animals in vaccine production and control: Replacement, reduction and refinement

byC.F.M. Hendriksen

Paperback | October 3, 2011

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9. REFERENCES 90 CHAPTER 9: OPPORTUNITIES FOR REPLACEMENT, REDUCTION AND REFINEMENT: HUMAN VIRAL VACCINES 93 1. INTRODUCTION 93 2. TESTS FOR EXTRANEOUS MICROORGANISMS 94 3. MUMPS VACCINE . . . 94 4. HEPATITIS B VACCINE 95 4. 1. Test for freedom from live hepatitis virus 95 4. 2. Potency test 95 5. INFLUENZA VACCINE 96 5. 1. Potency test 96 5. 2. Abnormal-toxicity test 96 6. MEASLES VACCINE. . . . . 96 6. 1. Tests for extraneous agents 97 6. 1. 1. Test for Mycobacterium tuberculosis 97 6. 1. 2. Test for extraneous viruses 97 6. 2. Abnormal-toxicity test 98 7. POLIOMYELITIS VACCINE. . . 99 7. A. Inactivated poliomyelitis vaccine 99 7. A. l. Production. . . . . . 99 7. A. 2. Test for residual live virus 99 7. A. 3. Tests for extraneous agents 100 7. A. 3. l. Test for Mycobacterium tuberculosis . . . . . 100 7. A. 3. 2. Test for extraneous viruses 100 7. A. 4. Tumourigenicity test. . . . . 100 XII 7 . A. 5. Potency test . . . . . . . 101 7. A. 6. Test for abnormal toxicity 102 7. B. Live, oral poliomyelitis vaccine 103 7. B. l. Test for extraneous agents 103 7. B. 2. Test for neurovirulence 105 7. B. 3. Test for abnormal toxicity 106 8. RABIES VACCINE 106 8. 1. Production 106 8. 2. Test for residual live virus 107 8. 3. Tests for extraneous microorganisms 107 8. 3. 1. Test for Mycobacterium tuberculosis 107 8. 3. 2. Tests for extraneous viruses 108 8. 3. 2. 1. In dogs 108 8. 3. 2. 2.
Title:Laboratory animals in vaccine production and control: Replacement, reduction and refinementFormat:PaperbackPublished:October 3, 2011Publisher:Springer NetherlandsLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:9401070881

ISBN - 13:9789401070881

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Table of Contents

1: Introduction..- 2: Animal Experimentation and the Development of Vaccines: A Brief Historical Outline.- 1. The Ancient World.- 2. The 19Th Century.- 2.1. Claude Bernard.- 2.2. Louis Pasteur and Robert Koch.- 2.3. The beginnings of vaccine development.- 2.4. The rabies vaccine.- 3. The 20th Century.- 4. References.- 3: The Historical Role of Animal Experiments in the Development of Diphtheria Prophylaxis.- 1. Introduction.- 2. Clinico-Pathological Research.- 3. Diphtheria Prophylaxis.- 3.1. Development of the diphtheria antiserum.- 3.2. Toxin-antitoxin mixtures.- 3.3. Diphtheria toxoid.- 4. Quality Control.- 4.1. Historical development.- 4.2. The French and German methods.- 4.3. The influence of statistics.- 4.4. The "Kollektivversuch" or "group test".- 5. Recent Developments.- 6. References.- 4: Vaccine Development and Production.- 1. Development.- 2. Production.- 2.1. Bacterial vaccines.- 2.2. Virus vaccines.- 3. Vaccine Production in the Netherlands.- 4. Quality Control.- 4.1. Safety evaluation.- 4.2. Potency testing.- 5. Guidelines.- 6. Good Manufacturing Practice (GMP).- 7. References.- 5: Experimental Animals and Animal Experiments..- 1. Extent of the Research.- 2. Purpose of the Research.- 2.1. production.- 2.2. Quality control.- 2.2.1. Safety evaluation.- 2.2.2. Potency testing.- 3. Relevance of the Tests.- 4. Distress.- 5. References.- 6: Animal Experimentation and its Shortcomings.- 1. Introduction.- 2. Limitations of Animal Experimentation.- 2.1. Moral aspects.- 2.2. Economic aspects.- 2.3. Zootechnical aspects.- 2.4. Safety aspects.- 2.5. Practical aspects.- 3. References.- 7: Alternatives to and in Animal Experimentation.- 1. Definition.- 2. History.- 3. Possibilities.- 4. Approach.- 5. References.- 8: Opportunities for Replacement, Reduction or Refinement: Human Bacterial Vaccines.- 1. Introduction.- 2. Bcg Vaccine.- 2.1. Test for absence of virulent mycobacteria.- 2.2. Jensen test (skin reactivity test).- 2.3. Test for abnormal toxicity.- 3. Cholera Vaccine.- 3.1. Identity test.- 3.2. Test for specific toxicity.- 3.4. Potency test.- 3.5. Test for abnormal toxicity.- 4. Diphtheria Vaccine.- 4.1. Identity test.- 4.2. Test for specific toxicity.- 4.3. Potency test.- 4.3.1. Alternative methods.- 4.3.2. Reduction of group size.- 4.3.3. Summary of the opportunities for reducing the number of animals required for the potency testing of the diphtheria component in vaccines.- 4.4. Abnormal toxicity test.- 5. Pertussis Vaccine.- 5.1. Specific-toxicity test.- 5.2. Potency test.- 5.3. Test for endotoxins.- 5.4. Test for abnormal toxicity.- 5.5. Future.- 6. Tetanus Vaccine.- 6.1. Identity test.- 6.2. Test for specific toxicity.- 6.3. Potency test.- 6.3.1. Reduction of group size.- 6.4. Test for abnormal toxicity.- 7. Typhoid Vaccine.- 7.1. Test for endotoxins.- 7.2. Potency test.- 7.3. Test for abnormal/specific toxicity.- 8. Summary.- 9. References.- 9: Opportunities for Replacement, Reduction and Refinement: Human Viral Vaccines.- 1. Introduction.- 2. Tests for Extraneous Microorganisms.- 3. Mumps Vaccine.- 4. Hepatitis B Vaccine.- 4.1. Test for freedom from live hepatitis virus.- 4.2. Potency test.- 5. Influenza Vaccine.- 5.1. Potency test.- 5.2. Abnormal-toxicity test.- 6. Measles Vaccine.- 6.1. Tests for extraneous agents.- 6.1.1. Test for Mycobacterium tuberculosis.- 6.1.2. Test for extraneous viruses.- 6.2. Abnormal-toxicity test.- 7. Poliomyelitis Vaccine.- 7.A. Inactivated poliomyelitis vaccine.- 7.A.1. Production.- 7.A.2. Test for residual live virus.- 7.A.3. Tests for extraneous agents.- 7.A.3.1. Test for Mycobacterium tuberculosis.- 7.A.3.2. Test for extraneous viruses.- 7.A.4. Tumourigenicity test.- 7.A.5. Potency test.- 7.A.6. Test for abnormal toxicity.- 7.B. Live, oral poliomyelitis vaccine.- 7.B.1. Test for extraneous agents.- 7.B.2. Test for neurovirulence.- 7.B.3. Test for abnormal toxicity.- 8. Rabies Vaccine.- 8.1. Production.- 8.2. Test for residual live virus.- 8.3. Tests for extraneous microorganisms.- 8.3.1. Test for Mycobacterium tuberculosis.- 8.3.2. Tests for extraneous viruses.- 8.3.2.1. In dogs.- 8.3.2.2. In mice.- 8.4. Potency test.- 8.5. Test for abnormal toxicity.- 9. Rubella Vaccine.- 9.1. Production.- 9.2. Tests for extraneous agents.- 9.3. Abnormal-toxicity test.- 10. Summary.- 11. References.- 10: Opportunities for Replacement, Reduction or Refinement: Poultry Vaccines.- 1. Introduction.- 2. Live, Attenuated Poultry Vaccines.- 2.1. Tests for contamination with extraneous agents.- 2.1.1. Test for extraneous agents in chicks.- 2.1.2. Test for contamination with avian encephalomyelitis virus in chick embryos or day-old chicks.- 2.2. Safety evaluation.- 2.3. Titration of the attenuated avian encephalomyelitis vaccine virus.- 2.4. Titration of the attenuated fowlpox vaccine virus.- 2.5. General.- 3. Inactivated Poultry Vaccines.- 3.1. Testing the potency of two or more vaccines in a single experiment.- 3.2. Combining the potency test and the safety test.- 3.3. Sequential testing.- 4. Summary.- 5. References.- 11: Opportunities for Replacement, Reduction or Refinement: Veterinary Vaccines For Mammals..- 1. Introduction.- 2. Safety Evaluation (general).- 3. Vaccines for Dogs.- 3.1. Potency test on inactivated vaccines.- 3.1.1. Leptospirosis vaccine.- 3.1.2. Canine parvovirus, hepatitis (HCC) and distemper vaccines.- 3.1.3. Rabies vaccine.- 3.2. Potency tests on live, attenuated vaccines.- 3.3. Test for freedom from contaminating rabies virus.- 4. Vaccines for Horses.- 4.1. Potency test on influenza vaccine.- 4.2. Potency test on tetanus vaccine.- 5. Vaccines for Cattle.- 5.1. Potency test on Brucella abortus vaccine.- 5.2. Potency test on footh-and-mouth disease vaccine.- 5.3. Safety test on foot-and-mouth disease vaccine.- 5.4. Potency test on E. coli vaccine.- 6. Vaccines for Pigs.- 6.1. Potency test on clostridial vaccines.- 6.2. Potency test on swine influenza vaccine.- 6.3. Potency test on vaccines against atrophic rhinitis, E. coli infection and swine erysipelas.- 7. Summary.- 7.1. Dogs.- 7.2. Cat.- 7.3. Horse.- 7.4. Cattle.- 7.5. Pig.- 8. References.- 12: Replacement, Reduction or Refinement: An Indirect Approach.- 1. Introduction.- 2. Harmonizing the Guidelines.- 3. Reviewing the Need for Re-Testing by the National Control Authorities.- 4. Combining Several Tests.- 5. Using Inbred Animal Strains.- 6. Increasing the Size of Vaccine Batches.- 7. Relaxing The Body Weight Specifications.- 8. Re-Using Animals.- 9. Using Specific Pathogen-Free (Spf) Animals.- 10. Reducing or Suppressing Pain.- 11. References.- 13: Future Prospects.- 1. Introduction.- 2. Vaccine Production.- 2.1. Subunit vaccines.- 2.2. Synthetic peptide vaccines.- 2.3. Idiotype vaccines.- 3. Vaccine Control.- 3.1. Safety evaluation.- 3.2. Potency testing.- 4. References.- 14: Final Comments and Recommendations.

Editorial Reviews

`All who work in the area of vaccine production and control or who are concerned for the welfare of animals should read this book and act on its recommendations.'
Australian Veterinary Journal, 67 (12) December 1990