Application of the consistency approach to reduce animal use in vaccine potency testing

Author:

Kulpa-Eddy Jodie,Dusek David

Publisher

Elsevier BV

Subject

Infectious Diseases,Drug Discovery,Pharmaceutical Science,Immunology

Reference17 articles.

1. Quoted in Monke J. The Virus-Serum-Toxin Act: A Brief History and Analysis. CRC Report for Congress. Washington, DC: Congressional Research Service, 2005. Available at: http://www.nationalaglawcenter.org/assets/crs/RS22014.pdf.

2. U.S. Biologics Control Act of 1902.

3. ANON (1960). The Pharmaceutical Affairs Law. Japan Law No. 145 in 1960, as amended on 26 June 1996. Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, Yakugyo Jiho, Japan, 2-91 (in Japanese and English).

4. Directive 2001/82/EC of The European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Official Journal of the European Communities, 2001.

5. Directive, 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Communities, 2001.

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