- The globalization of pediatric clinical trialsJulia Dunne
Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA
Pediatrics 130:e1583-91. 2012..To examine the characteristics of pediatric trials conducted under US legislation and to compare results with data from 2002 to 2007...
- The European Regulation on medicines for paediatric useJulia Dunne
Medicines and Healthcare products Regulatory Agency, 1 Nine Elms Lane, London SW8 9NQ UK
Paediatr Respir Rev 8:177-83. 2007..All medicines authorised for a paediatric use will be identified by a new symbol on the package label. After 5 years, there will be a stocktake with a view to making changes to the Regulation if necessary...
- Extrapolation of adult data and other data in pediatric drug-development programsJulia Dunne
Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA
Pediatrics 128:e1242-9. 2011..We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time...