title: Juvenile animal toxicity study designs to support pediatric drug development.
abstract: The objective of juvenile animal toxicity studies of pharmaceuticals is to obtain safety data, including information on the potential for adverse effects on postnatal growth and development. Studies in juvenile animals may assist in identifying postnatal developmental toxicities or other adverse effects that are not adequately assessed in the routine toxicity evaluations and that cannot be safely or adequately measured in pediatric clinical trials. Unlike the traditional reproductive and developmental toxicology studies that have been discussed in the accompanying reports, the design requirements for toxicity studies in juvenile animals are not explicitly defined in regulatory guidance. However, studies in juvenile animals can be useful in providing safety information necessary to enable pediatric clinical trials in pediatric patients or when there are special concerns for toxicities that cannot be safely or adequately measured in clinical trials. These juvenile animal toxicity studies are designed on a case-by-case basis. General design considerations and examples of study designs for assessment of juvenile animal toxicity are discussed.
authors.affiliation: Pfizer Global Research and Development, Groton Laboratories, Connecticut 06340, USA. Gregg.d.cappon@pfizer.com
authors.forename: Gregg D
authors.initials: GD
authors.lastname: Cappon
authors.forename: Graham P
authors.initials: GP
authors.lastname: Bailey
authors.forename: Jochen
authors.initials: J
authors.lastname: Buschmann
authors.forename: Maureen H
authors.initials: MH
authors.lastname: Feuston
authors.forename: J Edward
authors.initials: JE
authors.lastname: Fisher
authors.forename: Kok Wah
authors.initials: KW
authors.lastname: Hew
authors.forename: Alan M
authors.initials: AM
authors.lastname: Hoberman
authors.forename: Yojiro
authors.initials: Y
authors.lastname: Ooshima
authors.forename: Donald G
authors.initials: DG
authors.lastname: Stump
authors.forename: Mark E
authors.initials: ME
authors.lastname: Hurtt
mesh_terms: D000818:Animals; D000830:Animals, Laboratory; D000831:Animals, Newborn; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D048788:Growth and Development / Q000187:drug effects*; D008297:Male; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000145:classification; D051381:Rats; D011919:Rats, Inbred Strains; D012107:Research Design; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations