1. Guideline on clinical trials in small populations http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003615.pdf
2. ICH Topic E 11Clinical Investigation of Medicinal Products in the Paediatric Population http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf
3. Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population (CHMP/EWP/147013/04 Corrigendum) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003066.pdf
4. Guidance for Industry, Exposure-Response Relationships, Study Design, Data Analysis, and Regulatory Applications http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072109.pdf