1. Federal Register Regulations requiring manufacturers to assess the safety and effectiveness of new drugs for pediatric patients 1998
2. United States Food and Drug Administration (FDA) Guidance document. nonclinical safety evaluation of pediatric drug products 2006
3. http://ec.europa.eu/enterprise/pharmaceuticals/endralex/vol-1/reg_2006_1901/ reg_2006_1901_en.pdf
4. European Medicines Agency (EMEA)/Committee for Human Medicinal Products (CHMP) Guideline on the need for nonclinical testing in juvenile animals on human pharmaceuticals for paediatric indications 2008
5. 2005