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Essentials of Translational Pediatric Drug Development

From Past Needs to Future Opportunities

Specificaties
Paperback, blz. | Engels
Elsevier Science | e druk, 2024
ISBN13: 9780323884594
Rubricering
Elsevier Science e druk, 2024 9780323884594
€ 187,00
Levertijd ongeveer 8 werkdagen

Samenvatting

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.

Specificaties

ISBN13:9780323884594
Taal:Engels
Bindwijze:Paperback

Inhoudsopgave

Section 1: From past to current needs in pediatric drug research<br>1. Preface: overview of pediatric drug development and pharmacovigilance<br>2. Historical perspective<br>3. Parents' and children's needs in the drug development process<br>4. The needs from the regulatory authorities&rsquo; perspective – current status and worldwide initiatives<br>5. Optimal pediatric therapeutic development – the partnership between patients/families/industry and academia: the pharmaceutical industry&rsquo;s perspective<br>6. The needs, challenges and opportunities from the academic researchers&rsquo; perspective<br>7. The needs from a health care provider&rsquo;s perspective<br><br>Section 2: Designing pediatric drug research: from bench to bedside and back<br>8. Application of in vitro models<br>9. Application of preclinical juvenile animal models<br>10. Application of pediatric adapted modelling and simulation approaches<br>11. The promise of omics approaches for pediatric drug development<br>12. Generation and interpretation of big data in pediatric drug development<br>13. Investigational Medicinal Product considerations in pediatric clinical drug trials<br>14. Co-designing pediatric clinical trials with multi-stakeholders: a step by step approach<br><br>Section 3: Improving the performance of pediatric drug research: big changes start with small steps<br>15. Principles of performing pediatric clinical drug trials<br>16. Regulatory considerations in the design and conduct of pediatric clinical trials<br>17. Ethical considerations in the design and conduct of pediatric clinical trials<br>18. Performing clinical drug trials in acute and critically ill neonates and children<br>19. Performing clinical drug trials in children with a rare disease<br>20. Policy of pediatric oncology drug development<br>21. Practice of pediatric oncology drug development<br>22. Pediatric drug formulations<br>23. Worldwide network initiatives in improving pediatric drug research<br>24. The patients&rsquo;/parents&rsquo; voice within pediatric drug research<br>25. Pediatric drug development issues during public health emergencies<br><br>Section 4: Future perspectives in pediatric drug research: the road to better drugs for children<br>26. Future of pediatric drug research from different stakeholder perspectives
€ 187,00
Levertijd ongeveer 8 werkdagen

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        Essentials of Translational Pediatric Drug Development