Research and Markets: Global Pediatric Drug Development & Regulatory Challenges and Commercial Opportunities

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/bglqvv/pediatric_drug) has announced the addition of the "Pediatric Drug Development - Regulatory Challenges and Commercial Opportunities" report to their offering.

Pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).

Key Reasons to Purchase:

• Reviews the current regulatory landscape and helps sponsors to understand the potential impact of FDA SIA regulations and the variations between EU regulation on global pediatric plans;
• Identifies the key challenges associated with pediatric drug development and the ways to overcome these hurdles;
• Assesses what issues need to be addressed in order to improve access to pediatric medicines and commercial opportunities in transition countries based on KOL insights;
• Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields in neonates, rare and neglected pediatric diseases and pediatric vaccines.

Key Topics Covered:

1. Executive summary
2. How commercially attractive is pediatric drug development?
3. Why should pharma invest in pediatric medicines?
4. Methodology
5. Pediatric medicines: an overview
6. The pediatric population
7. Underlying/key issues for pediatric drug development
8. Unmet clinical needs
9. Current landscape
10. Regulation and legislation
11. Global harmonization
12. Strategic considerations for developing geriatric medicines
13. Clinical trial considerations
14. Pediatric formulation issues
15. Pediatric networks
16. Patient access
17. Commercial opportunities
18. Generic formulations and dosage forms
19. Rare and neglected diseases
20. Pediatric vaccines
21. Appendix

For more information visit http://www.researchandmarkets.com/research/bglqvv/pediatric_drug