1. General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products. Draft Guidance for Industry. 2014.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425885.pdf
.
2. Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonate. 2007.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003750.pdf
.
3. International Conference on Harmonization: Clinical Investigation of Medicinal Products in the Pediatric Population E11. 2000.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/ICH_E11_R1_Step_2_25Aug2016_Final.pdf
.
4. Tri-Council policy statement 2: ethical conduct for research involving humans. 2014.
http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
.
http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/Highlights_of_Changes_EN.pdf
.
5. Survey of Current Guidance for Child Health Clinical Trials. The StaR Child Health Project: Standards for Research with Children. 2009.
http://www.who.int/childmedicines/publications/GUIDANCECHILDHEALTH.pdf
.