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.- Covers both theoretical and practical aspects of translational pediatric drug development- Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups)- Offers best practices and future perspectives for the improvement of translational pediatric drug development
Table of Contents
Section 1: From past to current needs in pediatric drug research1. Preface: overview of pediatric drug development and pharmacovigilance2. Historical perspective3. Parents' and children's needs in the drug development process4. The needs from the regulatory authorities' perspective – current status and worldwide initiatives5. Optimal pediatric therapeutic development – the partnership between patients/families/industry and academia: the pharmaceutical industry's perspective6. The needs, challenges and opportunities from the academic researchers' perspective7. The needs from a health care provider's perspectiveSection 2: Designing pediatric drug research: from bench to bedside and back8. Application of in vitro models9. Application of preclinical juvenile animal models10. Application of pediatric adapted modelling and simulation approaches11. The promise of omics approaches for pediatric drug development12. Generation and interpretation of big data in pediatric drug development13. Investigational Medicinal Product considerations in pediatric clinical drug trials14. Co-designing pediatric clinical trials with multi-stakeholders: a step by step approachSection 3: Improving the performance of pediatric drug research: big changes start with small steps15. Principles of performing pediatric clinical drug trials16. Regulatory considerations in the design and conduct of pediatric clinical trials17. Ethical considerations in the design and conduct of pediatric clinical trials18. Performing clinical drug trials in acute and critically ill neonates and children19. Performing clinical drug trials in children with a rare disease20. Policy of pediatric oncology drug development21. Practice of pediatric oncology drug development22. Pediatric drug formulations23. Worldwide network initiatives in improving pediatric drug research24. The patients'/parents' voice within pediatric drug research25. Pediatric drug development issues during public health emergenciesSection 4: Future perspectives in pediatric drug research: the road to better drugs for children26. Future of pediatric drug research from different stakeholder perspectives
