Considering the Patient in Pediatric Drug Development
eBook - ePub

Considering the Patient in Pediatric Drug Development

How Good Intentions Turned Into Harm

  1. 414 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Considering the Patient in Pediatric Drug Development

How Good Intentions Turned Into Harm

About this book

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child."In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.- Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents- Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research- Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information

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Yes, you can access Considering the Patient in Pediatric Drug Development by Klaus Rose in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmaceutical, Biotechnology & Healthcare Industry. We have over one million books available in our catalogue for you to explore.

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. Foreword by Jane M. Grant-Kels
  6. Foreword by David Neubauer
  7. Rumpelstiltskin and the miller’s daughter
  8. Conclusion and outlook
  9. Abbreviations and technical explanations
  10. Background
  11. Introduction
  12. Chapter 1. The process of modern drug development and the challenge of young patients
  13. Chapter 2. US and EU pediatric legislation
  14. Chapter 3. A paradigm shift
  15. Chapter 4. Introduction: specific disease areas
  16. Chapter 5. Neonatology
  17. Chapter 6. Challenges at the interface of science, drug development, and drug approval beyond specific disease areas
  18. Chapter 7. Juvenile animal studies
  19. Chapter 8. Child-friendly formulations: tablets, quick-dissolving formulations, liquids, and more
  20. Chapter 9. What do young patients really need?
  21. Index