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Decision tree for pre-clinical toxicology testing for vaccines, showing protocols to ensure product safety. The process begins with a question as to whether the vaccine has been used in humans at the proposed doses; if no, this leads to a repeated dose toxicology study. Results from repeated dose toxicology studies will provide information for clinical protocol design and are submitted to IND. The next consideration is a biodistribution study and its results, which are submitted to IND. An integration study may be required (if the vaccine did not clear over time from tissues to which it was originally distributed), with results also submitted to IND. Final questions for consideration include delivery route, whether the vaccine is a live replicating organism, and whether it is supposed to be attenuated for virulence; the answers may indicate that product-specific safety studies are needed. If the product will be given to pregnant or child-bearing women, reproductive or developmental toxicology studies may be required. If the vaccine has oncogenic potential or if the cell substrate is tumorigenic, oncogenicity or carcinogenesis studies may be required. CBER should be consulted in these instances for study guidance.

Last Updated June 03, 2008