Paediatric extrapolation: A necessary paradigm shift
Author:
Affiliation:
1. European Medicines Agency 30 Churchill Place, Canary Wharf London E14 5EU UK
2. Food and Drug Administration 10903 New Hampshire Ave Silver Spring MD USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.13809
Reference17 articles.
1. Paediatric drug use with focus on off‐label prescriptions at Swedish hospitals – a nationwide study
2. European Union.Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92 Directive 2001/20/EC Directive 2001/83/EC and Regulation (EC) No 726/2004. Available athttps://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf(last accessed 1 June 2018).
3. More medicines for children: impact of the EU paediatric regulation
4. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study
5. European Medicines Agency.10‐year report to the European Commission.2017. Available athttps://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/paediatrics_10_years_ema_technical_report.pdf(last accessed 1 June 2018).
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