title: Non-clinical development of cancer vaccines: regulatory considerations.
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.
authors.affiliation: Igeneon Immunotherapy of Cancer, Brunner Strasse 69/3, 1230 Vienna, Austria. chabicovsky@granzer.biz
authors.forename: Monika
authors.initials: M
authors.lastname: Chabicovsky
authors.forename: Peter
authors.initials: P
authors.lastname: Ryle
mesh_terms: 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
chemical_list: D019496:Cancer Vaccines; D019444:Vaccines, DNA