An improved abnormal toxicity test by using reference vaccine-specific body weight curves and histopathological data for monitoring vaccine quality and safety in Japan

Author:

Mizukami Takuo,Masumi Atsuko,Momose Haruka,Kuramitsu Madoka,Takizawa Kazuya,Naito Seishiro,Maeyama Jun-ichi,Furuhata Keiko,Tsuruhara Momoka,Hamaguchi Isao,Yamaguchi Kazunari

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference21 articles.

1. A short history of vaccination;Plotkin,2008

2. Regulation and testing of vaccines;Baylor,2008

3. General Considerations for combined vaccine;WHO Expert Committee on Biological Standardization. 30th Report;WHO Tech Rep Ser,1979

4. Minimum requirements for biological products, Japan, National Institute of Infectious Diseases, http://www.nih.go.jp/niid/MRBP/seibutsuki_english.pdf.

5. Code of Federal Regulations. Title 21, Vol. 7, CITE: 21 CFR 610.11, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.11.

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