1. U.S. FDA, Center for Drug Evaluation and Research Nonclinical Safety Evaluation of Pediatric Drug Products 2006
2. European Medicines Agency (EMA), Committee for Human Medicinal Products (CHMP) Guideline on the Need for Non-clinical Testing in Juvenile Animals on Human Pharmaceuticals for Pediatric Indications 2008
3. Guidance on the non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals 2009
4. Value of juvenile animal studies;Leconte;Birth Defects Research (Part B),2011
5. The value of juvenile animal studies “What have we learned from preclinical juvenile toxicity studies? II;Bailey;Birth Defects Research (Part B),2011