Three Rs Approaches in the Production and Quality Control of Avian Vaccines

ECVAM (1994). ECVAM News & Views. ATLA 22, 7–11.

Council of Europe (1999). Avian Infectious Encephalomyelitis Vaccine (Live). Pharmeuropa 11, 158–160.

Council of Europe (1999). Avian Infectious Bursal Disease Vaccine (Live). Pharmeuropa 11, 160–163.

Council of Europe (1999). Avian Infectious Bronchitis Vaccine (Live). Pharmeuropa 11, 163–166.

Council of Europe (1999). Duck Viral Hepatitis Type 1 Vaccine (Live). Pharmeuropa 11, 166–168.

Council of Europe (1999). Fowl-pox Vaccine (Live). Pharmeuropa 11, 168–170.

Council of Europe (1999). Newcastle Disease Vaccine (Live). Pharmeuropa 11, 170–172.

Council of Europe (1999). Marek's Disease Vaccine (Live). Pharmeuropa 11, 172–175.

Council of Europe (1999). Avian Infectious Laryngotracheitis Vaccine (Live). Pharmeuropa 11, 175–177.

Council of Europe (1999). 2.6.3. Avian Viral Vaccines: Tests for Extraneous Agents in Seed Lots. Pharmeuropa 11, 188–191.

Council of Europe (1999). 2.6.4. Avian Live Virus Vaccines: Tests for Extraneous Agents in Batches of Finished Product. Pharmeuropa 11, 191–193.

Council of Europe (1999). Avian Viral Tenosynovitis Vaccine (Live). Pharmeuropa 11, 156–158.

Council of Europe (1997). Avian Infectious Bronchitis Vaccine (Inactivated). In European Pharmacopoeia, 3rd edn. Strasbourg, France: Council of Europe.

Council of Europe (1997). Avian Infectious Bursal Vaccine (Inactivated). In European Pharmacopoeia, 3rd edn. Strasbourg, France: Council of Europe.

Council of Europe (1998). Egg Drop Syndrome ‘76 Vaccine (Inactivated). European Pharmacopoeia, 3rd edn, Suppl. Strasbourg, France: Council of Europe.

Council of Europe (1997). Newcastle Disease Vaccine (Inactivated). European Pharmacopoeia, 3rd edn. Strasbourg, France: Council of Europe.

Häuptli D. , Bruckner L. , & Ottiger H.P. (1997). Use of reverse transcriptase polymerase chain reaction for detection of vaccine contamination by avian leukosis virus. Journal of Virological Methods 66, 77–81.

Council of Europe (1997). 5.2.2. Chicken flocks free from specified pathogens for the production and quality control of vaccines. European Pharmacopoeia, 3rd edn. Strasbourg, France: Council of Europe.

Tagaki M. , Ishikawa K. , Nagai H. , Sasaki T. , Gotoh K. , & Koyama H. (1996). Detection of contamination of vaccines with the reticuloendotheliosis virus by reverse transcriptase polymerase chain reaction (RT-PCR). Virus Research 40, 113–121.

Falcone E. , Tarantino M. , Massi P. , Di Pasquale I. , Vignolo E. , & Tollis M. (2000). Detection of vaccine contamination by chicken anaemia virus by polymerase chain reaction. In Proceedings of the 3rd World Congress on Alternatives and Animal Use in the Life Sciences (ed. Balls M. , van Zeller A-M. , & Halder M. ), in press.

Stäuber N. , Brechtbühl K. , Bruckner L. , & Hofmann M.A. (1995). Detection of Newcastle disease virus in poultry vaccines using polymerase chain reaction and direct sequencing of amplified cDNA. Vaccine 13, 360–364.

Falcone E. , D'Amore E. , Di Trani L. , Puzelli S. , & Tollis M. (1997). Detection of avian infectious bronchitis virus in poultry vaccines by the polymerase chain reaction. In Animal Alternatives, Welfare and Ethics (ed. van Zutphen L.F.M. , & Balls M. ), pp. 1007–1012. Amsterdam, The Netherlands: Elsevier.

Vögtlin A. , Bruckner L. , & Ottiger H-P. (1999). Use of polymerase chain reaction (PCR) for the detection of vaccine contamination by infectious laryngotracheitis vaccine. Vaccine 17, 2501–2506.

Hess M. , Raue R. , & Fafez H.M. (1999). PCR for specific detection of haemorrhagic enteritis virus of turkeys, an avian adenovirus. Journal of Virological Methods 81, 199–203.

Council of Europe (1997). Vaccines for veterinary use. In European Pharmacopoeia, 3rd edn. Strasbourg, France: Council of Europe.

Council of Europe (1997). Multilateral consultation of parties to the European convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS 123). Council of Europe: Report of the meeting, Strasbourg, 30 June 1997.

EEC (1986). 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 of the European Communities L358, 1–29.

Roberts B. , & Lucken R.N. (1996). Reducing the use of the target animal batch safety test for veterinary vaccines. In Replacement, Reduction and Refinement of Animal Experiments in the Development and Control of Biological Products (ed. Brown F. , Cussler K. , & Hendriksen C. ), pp. 97–102. Basel, Switzerland: S. Karger.

Weisser K. , & Hechler U. (1997). Animal Welfare Aspects in the Quality Control of Immunobiologicals: A Critical Evaluation of Animal Tests in Pharmacopoeial Monographs, 348 pp. Nottingham, UK: FRAME.

Zeegers J.J.W. , de Vries W.F. , & Remie R. (1997). Reducing the use of animals by abolishment of the safety test as a routine batch control test on veterinary vaccines. In Animal Alternatives, Welfare and Ethics (ed. van Zutphen L.F.M. , & Balls M. ), pp. 1003–1005. Amsterdam, The Netherlands: Elsevier.

Van der Heide L. (1989). Encephalomyelitis monograph. In Laboratory Manual for the Isolation of Avian Pathogens. American Association of Avian Pathologists, 3rd edn (ed. Arp L.H. , Domermoth C. , & Pearson J.E. ), pp. 149–151. Dubuque, IA, USA: Kendall/Hunt Publishing Company.

Maas R.A. , Oei H.L. , Kemper S. , Koch G. , & Visser L. (1998). The use of homologous virus in the haemagglutination-inhibition assay after vaccination with Newcastle disease virus strain La Sota or clone 30 leads to an overestimation of protective serum antibody titers. Avian Pathology 27, 625–631.

Maas R.A. , Oei H.L. , Venema-Kemper S. , Koch G. , & Bongers J. (2000). Dose–response effects of inactivated Newcastle disease vaccines: influence of serological assay, the time after vaccination and type of chickens. Avian Disease, in press.

Maas R. , de Winter M. , Koch G. , Oei H. , & Bongers J. (2000). Development of an in vitro potency test for inactivated Newcastle disease vaccines. In Proceedings of the 3rd World Congress on Alternatives and Animal Use in the Life Sciences (ed. Balls M. , van Zeller A-M. , & Halder M. ), in press.

Sachs L. (1984). Applied Statistics: A Handbook of Techniques, 2nd edn, 701 pp. New York, USA: Springer.

Anon (1997). S-PLUS 4 Guide to Statistics. Seattle, WA, USA: Data Analysis Products Division, MathSoft, 425 pp.

Fleiss J. L. (1981). Statistical Methods for Rates and Proportions, 2nd edn, 321 pp. New York, USA: Wiley.

Hothorn L. A. , Lin K.K. , Hamada C. , & Rebel W. (1997). Recommendations for biostatistics of repeated toxicity studies. Drug Information Journal 31, 327–334.