Considering the Patient in Pediatric Drug Development How Good Intentions Turned Into Harm

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  • Engels
  • Paperback
  • 9780128238882
  • 20 november 2020
  • 414 pagina's
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Samenvatting

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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Inhoud

Taal
en
Bindwijze
Paperback
Oorspronkelijke releasedatum
20 november 2020
Aantal pagina's
414

Betrokkenen

Hoofdauteur
Klaus Rose
Hoofduitgeverij
Academic Press Inc

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Product breedte
152 mm
Product lengte
229 mm
Studieboek
Nee
Verpakking breedte
152 mm
Verpakking hoogte
229 mm
Verpakking lengte
229 mm
Verpakkingsgewicht
630 g

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EAN
9780128238882

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