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

Biologicals

Volumn 37, Issue 1, 2009, Pages 8-17

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

^a NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Japan)

Author keywords

Abnormal toxicity test; General safety test; Quality control; Vaccine

Indexed keywords

VACCINE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DRUG MONITORING; DRUG QUALITY; DRUG SAFETY; EVALUATION; FEMALE; HEMATOLOGY; HISTOPATHOLOGY; JAPAN; NONHUMAN; OBSERVATIONAL STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARD; STATISTICAL ANALYSIS; TOXICITY TESTING; WORLD HEALTH ORGANIZATION;

ANIMALS; BODY WEIGHT; CONSUMER PRODUCT SAFETY; DISEASE; FEMALE; GUINEA PIGS; JAPAN; MODELS, BIOLOGICAL; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL; RANDOM ALLOCATION; SPECIFIC PATHOGEN-FREE ORGANISMS; TOXICITY TESTS; VACCINATION; VACCINES, ATTENUATED;

ANIMALIA; CAVIA;

EID: 58149333690     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2008.07.007     Document Type: Article

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