References
- SEARCH for Diabetes in Youth Study Group; Liese AD, D’Agostino RB, Hamman RF et al. The burden of diabetes mellitus among US youth: prevalence estimates from the SEARCH for Diabetes in Youth Study. Pediatrics 118(4), 1510–1518 (2006).
- 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. Official Journal of the European Union L 378/1 (2006).
- TODAY Study Group. A clinical trial to maintain glycemic control in youth with Type 2 diabetes. N. Engl. J. Med. 366(24), 2247–2256 (2012).
- Bourgeois FT, Murthy S, Pinto C, Olson KL, Ioannidis JP, Mandl KD. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics 130(2), 285–292 (2012).
Websites
- EMA. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus (2012). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf (Accessed 17 January 2013)
- EMA. Concept paper on extrapolation of efficacy and safety in medicine development (Draft) (2012). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129285.pdf (Accessed 17 January 2013)
- Class waiver decision for PPAR-γ modulators. www.ema.europa.eu/docs/en_GB/document_library/Other/2009/11/WC500011743.pdf (Accessed 17 January 2013)
- Product specific waiver decision for vildagliptin. www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500115606.pdf (Accessed 17 January 2013)
- EMA investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes. www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/03/WC500140866.pdf (Accessed 9 March 2013)
- EMA paediatric workshops with stakeholders. www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000416.jsp&mid=WC0b01ac0580118a19 (Accessed 17 January 2013)
- The European Network of Paediatric Research at the EMA. www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000303.jsp&mid=WC0b01ac05801df74a (Accessed 17 January 2013)