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Considering the Patient in Pediatric Drug Development - How Good Intentions Turned Into Harm (Paperback)
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Considering the Patient in Pediatric Drug Development - How Good Intentions Turned Into Harm (Paperback)
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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.
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