An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs

Regul Toxicol Pharmacol. 2016 Aug:79:142-143. doi: 10.1016/j.yrtph.2016.03.001. Epub 2016 Mar 4.
No abstract available

Keywords: First in pediatric trials; Juvenile animal studies.

MeSH terms

  • Age Factors
  • Animals
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / standards
  • Drug Approval*
  • Drug Evaluation, Preclinical / methods*
  • Drug Evaluation, Preclinical / standards
  • Guidelines as Topic
  • Humans
  • Models, Animal
  • Patient Safety*
  • Research Design* / standards
  • Research Subjects*
  • Risk Assessment
  • Toxicity Tests
  • Vereinigte Staaten
  • United States Food and Drug Administration* / standards

Substances

  • Antineoplastic Agents