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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iii 6. Contributors - p. xi 7. Section I: From past to current needs in pediatric drug research - p. xv 8. Chapter 1. Preface: Overview of pediatric drug development and pharmacovigilance - p. 3 9. Chapter 2. Historical perspective - p. 21 10. Chapter 3. Parents' and children's needs in the drug development process - p. 33 11. Chapter 4. The needs from the regulatory authorities' perspective—current status and worldwide initiatives - p. 61 12. Chapter 5. Optimal pediatric drug development— the partnership between patients/parents, academia, regulatory authorities and industry: The pharmaceutical industry's perspective - p. 81 13. Chapter 6. The needs, challenges, and opportunities from the academic researchers' perspective - p. 93 14. Chapter 7. The health care provider's needs in the pediatric drug development process - p. 127 15. Section II: Designing pediatric drug research: From bench to bedside and back - p. 152 16. Chapter 8. Application of in vitro models for pediatric translational research - p. 155 17. Chapter 9. Application of preclinical juvenile animal models - p. 189 18. Chapter 10. Application of pediatric-adapted modeling and simulation approaches - p. 213 19. Chapter 11. The promise of omics approaches for pediatric drug development - p. 257 20. Chapter 12. Generation and interpretation of big data in pediatric drug development - p. 281 21. Chapter 13. Investigational medicinal products considerations in pediatric clinical drug trials - p. 303 22. Chapter 14. Co-designing pediatric clinical trials with multistakeholders: A step-by-step approach - p. 327 23. Section III: Improving the performance of pediatric drug research: Big changes start with small steps - p. 345 24. Chapter 15. Principles of performing pediatric clinical drug trials - p. 349 25. Chapter 16. Regulatory considerations in the design and conduct of pediatric clinical trials - p. 385 26. Chapter 17. Ethical consideration in the design and conduct of pediatric clinical trials - p. 421 27. Chapter 18. Performing clinical drug trials in acute and critically ill neonates and children - p. 451 28. Chapter 19. Performing clinical drug trials in children with a rare disease - p. 483 29. Chapter 20. Policy of pediatric oncology drug development - p. 509 30. Chapter 21. Practice of pediatric oncology drug development - p. 529 31. Chapter 22. Pediatric drug formulations - p. 561 32. Chapter 23. Worldwide network initiatives in improving pediatric drug research - p. 593 33. Chapter 24. The patients'/parents' voice within pediatric drug research - p. 629 34. Chapter 25. Pediatric drug development issues during public health emergencies - p. 663 35. Section IV: Future perspectives in pediatric drug research: The road to better drugs for children - p. 682 36. Chapter 26. The future of pediatric drug research: Science, context, and collaboration - p. 685 37. Index - p. 693
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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iii 6. Contributors - p. xi 7. Section I: From past to current needs in pediatric drug research - p. xv 8. Chapter 1. Preface: Overview of pediatric drug development and pharmacovigilance - p. 3 9. Chapter 2. Historical perspective - p. 21 10. Chapter 3. Parents' and children's needs in the drug development process - p. 33 11. Chapter 4. The needs from the regulatory authorities' perspective—current status and worldwide initiatives - p. 61 12. Chapter 5. Optimal pediatric drug development— the partnership between patients/parents, academia, regulatory authorities and industry: The pharmaceutical industry's perspective - p. 81 13. Chapter 6. The needs, challenges, and opportunities from the academic researchers' perspective - p. 93 14. Chapter 7. The health care provider's needs in the pediatric drug development process - p. 127 15. Section II: Designing pediatric drug research: From bench to bedside and back - p. 152 16. Chapter 8. Application of in vitro models for pediatric translational research - p. 155 17. Chapter 9. Application of preclinical juvenile animal models - p. 189 18. Chapter 10. Application of pediatric-adapted modeling and simulation approaches - p. 213 19. Chapter 11. The promise of omics approaches for pediatric drug development - p. 257 20. Chapter 12. Generation and interpretation of big data in pediatric drug development - p. 281 21. Chapter 13. Investigational medicinal products considerations in pediatric clinical drug trials - p. 303 22. Chapter 14. Co-designing pediatric clinical trials with multistakeholders: A step-by-step approach - p. 327 23. Section III: Improving the performance of pediatric drug research: Big changes start with small steps - p. 345 24. Chapter 15. Principles of performing pediatric clinical drug trials - p. 349 25. Chapter 16. Regulatory considerations in the design and conduct of pediatric clinical trials - p. 385 26. Chapter 17. Ethical consideration in the design and conduct of pediatric clinical trials - p. 421 27. Chapter 18. Performing clinical drug trials in acute and critically ill neonates and children - p. 451 28. Chapter 19. Performing clinical drug trials in children with a rare disease - p. 483 29. Chapter 20. Policy of pediatric oncology drug development - p. 509 30. Chapter 21. Practice of pediatric oncology drug development - p. 529 31. Chapter 22. Pediatric drug formulations - p. 561 32. Chapter 23. Worldwide network initiatives in improving pediatric drug research - p. 593 33. Chapter 24. The patients'/parents' voice within pediatric drug research - p. 629 34. Chapter 25. Pediatric drug development issues during public health emergencies - p. 663 35. Section IV: Future perspectives in pediatric drug research: The road to better drugs for children - p. 682 36. Chapter 26. The future of pediatric drug research: Science, context, and collaboration - p. 685 37. Index - p. 693
