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Published on: January 7, 2019
Non-clinical development of cancer vaccines: regulatory considerations
Monika Chabicovsky1, Peter Ryle
1Igeneon Immunotherapy of Cancer, Brunner Strasse 69/3, 1230 Vienna, Austria. chabicovsky@granzer.biz
Abstract:
This paper discusses regulatory requirements essential during the non-clinical development of cancer vaccines. DNA vaccines and vaccines containing monoclonal antibodies are specifically addressed. ICH, CHMP, FDA, and WHO guidance documents in addition to scientific literature are reviewed and the regulatory framework, including respective EMEA and the FDA divisions responsible for review and assessment of cancer vaccines, is described. Selection criteria for an appropriate animal model for efficacy and/or toxicity studies are discussed.
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