Considering the Patient in Pediatric Drug Development
  • Author : Klaus Rose
  • Release Date : 19 November 2020
  • Publisher : Academic Press
  • Genre : Business & Economics
  • Pages : 414
  • ISBN 13 : 9780128242056

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Book excerpt: 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

Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development

Author : Klaus Rose
Publisher : Academic Press
Genre : Business & Economics
Get 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 ...

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Publisher : John Wiley & Sons
Genre : Medical
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Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development....

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Publisher : Springer
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Publisher : National Academies Press
Genre : Medical
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Publisher : Wiley-Blackwell
Genre : Medical
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The first comprehensive treatmentof this vital topicFor decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with pediatric dosing of drugs that were developed and intended for adults. Now, an awareness ...