Full Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.
Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population.
Contents
Section 1: From past to current needs in pediatric drug research
1. Preface: overview of pediatric drug development and pharmacovigilance
2. Historical perspective
3. Parents' and children's needs in the drug development process
4. The needs from the regulatory authorities' perspective - current status and worldwide initiatives
5. Optimal pediatric therapeutic development - the partnership between patients/families/industry and academia: the pharmaceutical industry's perspective
6. The needs, challenges and opportunities from the academic researchers' perspective
7. The needs from a health care provider's perspective
Section 2: Designing pediatric drug research: from bench to bedside and back
8. Application of in vitro models
9. Application of preclinical juvenile animal models
10. Application of pediatric adapted modelling and simulation approaches
11. The promise of omics approaches for pediatric drug development
12. Generation and interpretation of big data in pediatric drug development
13. Investigational Medicinal Product considerations in pediatric clinical drug trials
14. Co-designing pediatric clinical trials with multi-stakeholders: a step by step approach
Section 3: Improving the performance of pediatric drug research: big changes start with small steps
15. Principles of performing pediatric clinical drug trials
16. Regulatory considerations in the design and conduct of pediatric clinical trials
17. Ethical considerations in the design and conduct of pediatric clinical trials
18. Performing clinical drug trials in acute and critically ill neonates and children
19. Performing clinical drug trials in children with a rare disease
20. Policy of pediatric oncology drug development
21. Practice of pediatric oncology drug development
22. Pediatric drug formulations
23. Worldwide network initiatives in improving pediatric drug research
24. The patients'/parents' voice within pediatric drug research
25. Pediatric drug development issues during public health emergencies
Section 4: Future perspectives in pediatric drug research: the road to better drugs for children
26. Future of pediatric drug research from different stakeholder perspectives
