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Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities

Editat de Elke Gasthuys, Karel Allegaert, Lien Dossche, Mark Turner
en Limba Engleză Paperback – 22 iul 2024
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
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Specificații

ISBN-13: 9780323884594
ISBN-10: 0323884598
Pagini: 728
Ilustrații: 130 illustrations (20 in full color)
Dimensiuni: 191 x 235 x 36 mm
Greutate: 1.45 kg
Editura: ELSEVIER SCIENCE

Cuprins

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

Recenzii

"This book discusses ethical considerations in pediatric clinical trials, pediatric trials for children with rare diseases, and cancer. It discusses these issues not only for the US but also for the European Union and worldwide network efforts for improving pediatric drug research.... The editors and authors of the book are credible experts in their fields based on their credentials. This book covers all matters of pediatric drug development. The book describes and discusses the three different approaches to pediatric drug development and the special issues and needs that arise due to the needs of pediatric patients.... It includes references and further readings at the end of each chapter.... The book provides a good, detailed background and description of the pediatric drug development process in the U.S. and in Europe and the special issues with pediatric drug development." --©Doody’s Review Service, 2024, Judith Klevan, B.A Biology B.S. Pharmacy (Einstein Medical Center)