Julia Dunne

Summary

Affiliation: Veterinary Laboratories Agency
Country: UK

Publications

  1. doi request reprint The globalization of pediatric clinical trials
    Julia Dunne
    Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA
    Pediatrics 130:e1583-91. 2012
  2. ncbi request reprint The European Regulation on medicines for paediatric use
    Julia Dunne
    Medicines and Healthcare products Regulatory Agency, 1 Nine Elms Lane, London SW8 9NQ UK
    Paediatr Respir Rev 8:177-83. 2007
  3. doi request reprint Extrapolation of adult data and other data in pediatric drug-development programs
    Julia Dunne
    Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA
    Pediatrics 128:e1242-9. 2011

Detail Information

Publications3

  1. doi request reprint The globalization of pediatric clinical trials
    Julia 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...
  2. ncbi request reprint The European Regulation on medicines for paediatric use
    Julia 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...
  3. doi request reprint Extrapolation of adult data and other data in pediatric drug-development programs
    Julia 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...