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Produktbild: Essentials of Translational Pediatric Drug Development
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Essentials of Translational Pediatric Drug Development

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137,99 € UVP 159,40 €

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Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

22.07.2024

Herausgeber

Elke Gasthuys + weitere

Verlag

Elsevier Science & Technology

Seitenzahl

728

Maße (B/H)

19/23,4 cm

Gewicht

1500 g

Sprache

Englisch

ISBN

978-0-323-88459-4

Beschreibung

Rezension

"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)

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

22.07.2024

Herausgeber

Verlag

Elsevier Science & Technology

Seitenzahl

728

Maße (B/H)

19/23,4 cm

Gewicht

1500 g

Sprache

Englisch

ISBN

978-0-323-88459-4

EU-Ansprechpartner

Elsevier B.V.
Radarweg 29
1043 NX Amsterdam
NL
productsafety@elsevier.com

Herstelleradresse

Elsevier Science & Technology
London Wall 125
EC2Y 5AS London
GB
tradeorders@elsevier.com

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  • Produktbild: Essentials of Translational Pediatric Drug Development
  • 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