Paediatric drug development: The impact of evolving regulations
| Autor: | Turner, Ma, Catapano, M, Hirschfeld, S, Giaquinto, Carlo, Grip |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Pediatrics
medicine.medical_specialty Extrapolation Pharmaceutical Science 030226 pharmacology & pharmacy Risk benefit ratio 03 medical and health sciences 0302 clinical medicine 030225 pediatrics Drug Discovery Animals Humans Pharmaceutical development Medicine Network of excellence Pharmacokinetics European Union Child Children's medicine business.industry Public relations Legislation Drug United States 3. Good health Pharmacodynamics Drug development Regulatory framework business Work Programme |
| Zdroj: | Advanced Drug Delivery Reviews. 73:2-13 |
| ISSN: | 0169-409X |
| Popis: | Children deserve medicines that are adapted to their needs. The need to include children in drug development has been recognised increasingly over the past few decades. Legal and regulatory frameworks are well established in the EU and US. The amount of work done to study medicines for children is significantly greater than it was 10years go. Proof-of-concept has been demonstrated for all segments of the paediatric drug development pipeline. It is now time to examine how the practice of developing medicines for children has evolved within those frameworks and to determine how that work should be generalised. This review describes the development of medicines for children and critically appraises the work that has been done within those frameworks. Significant effort is needed to realize the potential provided by the current regulatory framework. Using the work programme of the Global Research in Paediatrics (GRiP) Network of Excellence as a template we outline current work and future growing points. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect