Essentials of Translational Pediatric Drug Development
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Essentials of Translational Pediatric Drug Development
From Past Needs to Future Opportunities
Dossche, Lien; Gasthuys, Elke; Turner, Mark; Allegaert, Karel
Elsevier Science & Technology
06/2024
670
Mole
Inglês
9780323884594
Pré-lançamento - envio 15 a 20 dias após a sua edição
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SECTION 1: From past to current needs in pediatric drug research
1. Historical perspective
2. The needs from the regulatory authorities' perspective - worldwide initiatives
3. The needs from the pharmaceutical industry's perspective
4. The needs from the clinicians' perspective
5. The needs from the parents'/children' perspective
SECTION 2: Designing pediatric drug research: from bench to bedside and back
6. Different approaches: concepts and principles
7. Application of in vitro models
8. Application of preclinical juvenile animal models
9. Application of pediatric adapted modelling and simulation approaches
10. Application of multi-omics approaches
11. Generation and interpretation of big data
12. Designing pediatric clinical trials using different approaches from different stakeholder perspectives
SECTION 3: Improving the performance of pediatric drug research: big changes start with small steps
13. General principles of performing pediatric clinical drug trials
14. Regulatory considerations in the design and conduct of paediatric clinical trials
15. Performing clinical drug trials in acute and critically ill neonates and children
16. Performing clinical drug trials in chronically ill children
17. Performing clinical drug trials in pediatric rare diseases
18. Performing clinical drug trials in pediatric oncology
19. Pediatric drug formulations
20. Worldwide network initiatives in improving pediatric drug research
21. The need for an ethical framework to conduct pediatric drug research
22. The patients'/parents' voice within pediatric drug research
SECTION 4: Future perspectives in pediatric drug research: the road to better drugs for children
23. Future of pediatric drug research from different stakeholder perspectives
24. Concluding thoughts
1. Historical perspective
2. The needs from the regulatory authorities' perspective - worldwide initiatives
3. The needs from the pharmaceutical industry's perspective
4. The needs from the clinicians' perspective
5. The needs from the parents'/children' perspective
SECTION 2: Designing pediatric drug research: from bench to bedside and back
6. Different approaches: concepts and principles
7. Application of in vitro models
8. Application of preclinical juvenile animal models
9. Application of pediatric adapted modelling and simulation approaches
10. Application of multi-omics approaches
11. Generation and interpretation of big data
12. Designing pediatric clinical trials using different approaches from different stakeholder perspectives
SECTION 3: Improving the performance of pediatric drug research: big changes start with small steps
13. General principles of performing pediatric clinical drug trials
14. Regulatory considerations in the design and conduct of paediatric clinical trials
15. Performing clinical drug trials in acute and critically ill neonates and children
16. Performing clinical drug trials in chronically ill children
17. Performing clinical drug trials in pediatric rare diseases
18. Performing clinical drug trials in pediatric oncology
19. Pediatric drug formulations
20. Worldwide network initiatives in improving pediatric drug research
21. The need for an ethical framework to conduct pediatric drug research
22. The patients'/parents' voice within pediatric drug research
SECTION 4: Future perspectives in pediatric drug research: the road to better drugs for children
23. Future of pediatric drug research from different stakeholder perspectives
24. Concluding thoughts
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Pediatric drugs; Pediatric drug research; Pediatric drug development; Translational pediatric drug research; Pediatric preclinical drug trials; Pediatric clinical drug trials; Pediatric trial design; Regulatory, industry, academic, clinician, patient/parent perspective; Pediatric formulations; Ethics
SECTION 1: From past to current needs in pediatric drug research
1. Historical perspective
2. The needs from the regulatory authorities' perspective - worldwide initiatives
3. The needs from the pharmaceutical industry's perspective
4. The needs from the clinicians' perspective
5. The needs from the parents'/children' perspective
SECTION 2: Designing pediatric drug research: from bench to bedside and back
6. Different approaches: concepts and principles
7. Application of in vitro models
8. Application of preclinical juvenile animal models
9. Application of pediatric adapted modelling and simulation approaches
10. Application of multi-omics approaches
11. Generation and interpretation of big data
12. Designing pediatric clinical trials using different approaches from different stakeholder perspectives
SECTION 3: Improving the performance of pediatric drug research: big changes start with small steps
13. General principles of performing pediatric clinical drug trials
14. Regulatory considerations in the design and conduct of paediatric clinical trials
15. Performing clinical drug trials in acute and critically ill neonates and children
16. Performing clinical drug trials in chronically ill children
17. Performing clinical drug trials in pediatric rare diseases
18. Performing clinical drug trials in pediatric oncology
19. Pediatric drug formulations
20. Worldwide network initiatives in improving pediatric drug research
21. The need for an ethical framework to conduct pediatric drug research
22. The patients'/parents' voice within pediatric drug research
SECTION 4: Future perspectives in pediatric drug research: the road to better drugs for children
23. Future of pediatric drug research from different stakeholder perspectives
24. Concluding thoughts
1. Historical perspective
2. The needs from the regulatory authorities' perspective - worldwide initiatives
3. The needs from the pharmaceutical industry's perspective
4. The needs from the clinicians' perspective
5. The needs from the parents'/children' perspective
SECTION 2: Designing pediatric drug research: from bench to bedside and back
6. Different approaches: concepts and principles
7. Application of in vitro models
8. Application of preclinical juvenile animal models
9. Application of pediatric adapted modelling and simulation approaches
10. Application of multi-omics approaches
11. Generation and interpretation of big data
12. Designing pediatric clinical trials using different approaches from different stakeholder perspectives
SECTION 3: Improving the performance of pediatric drug research: big changes start with small steps
13. General principles of performing pediatric clinical drug trials
14. Regulatory considerations in the design and conduct of paediatric clinical trials
15. Performing clinical drug trials in acute and critically ill neonates and children
16. Performing clinical drug trials in chronically ill children
17. Performing clinical drug trials in pediatric rare diseases
18. Performing clinical drug trials in pediatric oncology
19. Pediatric drug formulations
20. Worldwide network initiatives in improving pediatric drug research
21. The need for an ethical framework to conduct pediatric drug research
22. The patients'/parents' voice within pediatric drug research
SECTION 4: Future perspectives in pediatric drug research: the road to better drugs for children
23. Future of pediatric drug research from different stakeholder perspectives
24. Concluding thoughts
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Pediatric drugs; Pediatric drug research; Pediatric drug development; Translational pediatric drug research; Pediatric preclinical drug trials; Pediatric clinical drug trials; Pediatric trial design; Regulatory, industry, academic, clinician, patient/parent perspective; Pediatric formulations; Ethics
