title: An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs.
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Hematology and Oncology Products, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States. Electronic address: john.leighton@fda.hhs.gov.
authors.forename: John K
authors.initials: JK
authors.lastname: Leighton
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Hematology and Oncology Products, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States.
authors.forename: Haleh
authors.initials: H
authors.lastname: Saber
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Hematology and Oncology Products, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States.
authors.forename: Gregory
authors.initials: G
authors.lastname: Reaman
authors.affiliation: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Hematology and Oncology Products, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D000367:Age Factors; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D023421:Models, Animal; D061214:Patient Safety; D012107:Research Design / Q000592:standards; D035842:Research Subjects; D018570:Risk Assessment; D018675:Toxicity Tests; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D000970:Antineoplastic Agents
keywords: First in pediatric trials; Juvenile animal studies