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LIBRERIA STUDIUM
Libreria medica internazionale
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LIBRERIA STUDIUM
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Pediatric Cancer Therapeutics Development
DiMartino, Reaman, Smith
Editore
Springer
Anno
2023
Pagine
181
ISBN
9783031063565
140,00 €

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This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.

  1. Front Matter

    Pages i-vi

    PDF

  2. History of Drug Development for Children with Cancer

    • Franklin O. Smith, Gregory H. Reaman

    Pages 1-8

  3. Targeted Small Molecule Drug Discovery

    • Jorge DiMartino

    Pages 9-24

  4. An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development

    • John K. Leighton, Whitney Helms

    Pages 25-30

  5. Design and Statistical Considerations for Early Phase Clinical Trials in Pediatric Oncology

    • Jirui Wang, Xiaofang Yan

    Pages 31-40

  6. Exploratory Clinical Development: From First in Humans to Phase 3 Ready

    • Jorge DiMartino

    Pages 41-49

  7. Gene and Cell Therapy: How to Build a BioDrug

    • Susanne Baumeister, Ann Woolfrey

    Pages 51-88

  8. The Pharma/Biotech Model for Drug Development: Implications for Pediatric Cancer Therapeutics

    • Peter T. C. Ho

    Pages 89-107

  9. Clinical Research Organizations

    • Gregory A. Hale, Jennifer Pullum

    Pages 109-121

  10. Role of Patients and Advocates in Cancer Therapeutics Development

    • Donna Ludwinski, Nicole Scobie, Leona Knox

    Pages 123-141

  11. The Role of Regulatory Agencies in Pediatric Cancer Drug Development

    • Martha Donoghue, Lori Ehrlich, Margret Merino, Sonia Singh, Dominik Karres, Franca Ligas et al.

    Pages 143-164

  12. Ethical Considerations in Pediatric Cancer Therapeutics Development

    • Melanie E. Bhatnagar, Donna L. Snyder

    Pages 165-176

  13. Future Directions

    • Jorge DiMartino

    Pages 177-181

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