3Department of Health and Human Services,Food and Drug Administration.Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final Rule:21CFR Parts201,312,314,601.Docket No.97N-0165 .
4Carol K Taketomo,Jane H Hodding,Donna M Kraus.Pediatric Dosage Handbook[]..
5Thomas J Moore,Sheila R Weiss,Sigal Kaplan,et al.Reported Adverse Drug Events in Infants and Children Under2Years of Age[].Pediatrics.2002
6.Food and Drug Administration Modernization Act of1997,Public Law105-115,105th Congress[].Stat.1997
7Buck ML.The FDA Modernization Act of1997:Impact on pediatric medicine[].Pediatric Pharmacotherapy.2000
8.Best practices in pediatric clinical trials expand with help of13PPRUs-Goal is to increase drug labeling for children[].Clinical Trials Administrator.2005
9A Saint-Raymond,N Seigneuret.The European paediatric initiative:1year of experience[].Pediatr Drugs.2009
10M Seibert-Grafe,R Butzer,F Zepp.German paediatric Research network (PAED-Net)[].Pediatr Drugs.2009
