Considering the Patient in Pediatric Drug Development - by Klaus Rose (Paperback)
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<p/><br></br><p><b> Book Synopsis </b></p></br></br><p><i>Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm</i> 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.</p> <p>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. </p><p/><br></br><p><b> Review Quotes </b></p></br></br><br>The book is educational and interesting. As a pharmacist who worked in a pediatric hospital for five years, I do think the book could have discussed some of the life-saving efforts of pediatric medicine as well. <b>--(c) Doody's Review Service, 2020, Judith Klevan, BA, BS(Einstein Medical Center Philadelphia), reviewer, expert opinion</b><br>
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