title: Value of juvenile animal studies.
abstract: The Developmental and Reproductive Toxicology Technical Committee of the ILSI Health and Environmental Sciences Institute has undertaken a project to address the impact of juvenile animal studies on pediatric drug development. A workshop, sponsored and organized by the Health and Environmental Sciences Institute Developmental and Reproductive Toxicity Technical Committee, was held on May 5-6, 2010, in Washington, DC, to discuss the outcome of a global survey and the value of juvenile animal studies in the development of drugs intended for use in pediatric patients. During this workshop, summary data from the 2009-2010 survey were presented, and breakout sessions were used to discuss specific case studies to try to assess the impact of juvenile animal studies performed to support specific pediatric drug development. The objectives of the Workshop on The Value of Juvenile Animal Studies were to (1) provide a forum for scientists representing industry, academia, and regulatory agencies to discuss the impact of juvenile animal studies on pediatric drug development, (2) evaluate summary data from the survey to understand how the juvenile study data are being used and their impact in labeling and risk assessment, (3) discuss selected case studies from the survey to highlight key findings, and (4) identify the areas of improvement for the designs of juvenile animal studies. The take home message that resonated from the workshop discussions was that well-designed juvenile animal studies have demonstrated value in support of certain pediatric drug development programs. However, it was also clear that a juvenile animal study is not always warranted.
authors.affiliation: Sanofi-Aventis Research and Development, Porcheville, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Leconte
authors.forename: Graham
authors.initials: G
authors.lastname: Bailey
authors.forename: Karen
authors.initials: K
authors.lastname: Davis-Bruno
authors.forename: Kok Wah
authors.initials: KW
authors.lastname: Hew
authors.forename: James
authors.initials: J
authors.lastname: Kim
authors.forename: Beatriz
authors.initials: B
authors.lastname: Silva Lima
authors.forename: Ulla
authors.initials: U
authors.lastname: Liminga
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Moffit
authors.forename: Luc
authors.initials: L
authors.lastname: De Schaepdrijver
authors.forename: Georg
authors.initials: G
authors.lastname: Schmitt
authors.forename: Melissa
authors.initials: M
authors.lastname: Tassinari
authors.forename: Kary
authors.initials: K
authors.lastname: Thompson
authors.forename: Mark
authors.initials: M
authors.lastname: Hurtt
mesh_terms: D000818:Animals; D000830:Animals, Laboratory / Q000254:growth & development*; D004353:Drug Evaluation, Preclinical; D023421:Models, Animal; D018570:Risk Assessment; D018675:Toxicity Tests