Non-clinical development of cancer vaccines: regulatory considerations.
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.
Chabicovsky
Monika
M
Igeneon Immunotherapy of Cancer, Brunner Strasse 69/3, 1230 Vienna, Austria. chabicovsky@granzer.biz
Ryle
Peter
P
D000818:Animals; D019496:Cancer Vaccines / Q000145:classification* / Q000494:pharmacology / Q000633:toxicity; D005060:Europe; D005069:Evaluation Studies as Topic; D017408:Guidelines as Topic; D006801:Humans; D007115:Immunization Schedule; D023421:Models, Animal; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D019444:Vaccines, DNA / Q000145:classification* / Q000494:pharmacology / Q000633:toxicity
D019496:Cancer Vaccines; D019444:Vaccines, DNA