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Rose

Considering the Patient in Pediatric Drug Development

How Good Intentions Turned into Harm

Jetzt vorbestellen! Wir liefern bei Erscheinen (Erscheint vsl. November 2020)

Buch. Softcover

2020

240 S

In englischer Sprache

William Andrew Publishing. ISBN 978-0-12-823888-2

Format (B x L): 15,2 x 22,9 cm

Produktbeschreibung

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 the historical roots why the United States (US) and European Union (EU) regulatory authorities, pediatric academia, and pharmaceutical industry demand, support and perform pediatric drug studies; the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child"; 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. Considering the Patient in Pediatric Drug Development helps healthcare professionals - and parents - to differentiate reasonable from questionable studies in young patients and navigate through the interface of good existing healthcare and fundamental flaws of pediatric clinical research and pediatric drug approval.


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 the conflicts of interest in performing and publishing "pediatric" research.
Helps to decipher justifications for pediatric studies and thus can help people to navigate the relevance of the information.

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