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

摘要: Vaccines differ from other pharmaceutical products. The quality and safety of batches are regulated to high standards by national regulatory authorities. Various control tests have been developed, including the abnormal toxicity test (ATT), which is described in World Health Organization (WHO) guidelines each country's pharmacopoeia. However, criteria for results not well defined these guidelines. In addition, animal grade be used ATT, classified on basis microbial colonization, was designated either guideline. this study, we report a new improved method performing statistical, histopathological analysis hematological findings. It based observation that there body weight changes characteristic vaccine, such standardized can as references evaluating vaccines. data useful determining vaccine safety. Combined with examination, ATT will great use consistency, different vaccine. analyses were similar using 'clean' or specific pathogen-free guinea pigs.