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

Rose MD MS, Klaus

Softcover

ISBN 10: 0128238887 ISBN 13: 9780128238882

Verlag: Academic Press, 2020

Inhaltsangabe

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.

Über diesen Titel

Über die Autorin bzw. den Autor

Dr. Klaus Rose is a medical doctor by training and profession. In the 1990s, after clinical training, he joined the pharmaceutical industry. In 1999 at Novartis in Switzerland, he came across clinical studies in children and was intrigued. His eldest daughter suffered from Sturge–Weber syndrome, which is serious and very rare. Dr. Rose became passionate about “pediatric drug development” and what the European Medicines Agency (EMA) called “Better Medicines for Children.” He became global head pediatrics at Novartis from 2001–2005 and moved to the same position 2005–2009 at Genentech/Roche. After one more year at a regulatory company, he became an independent consultant in 2011. He advises companies on EMA “pediatric investigation plans” (PIPs), and Food and Drug Administration (FDA) pediatric requests or demands. He detected fundamental flaws in “Pediatric Drug Development“ and publishes about this (and more) in peer-reviewed journals and medical textbooks.

Von der hinteren Coverseite

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 & 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.

Details zur Ausgabe

• Verlag: Academic Press
• Erscheinungsdatum: 2020
• Sprache: Englisch
• ISBN 10: 0128238887
• ISBN 13: 9780128238882
• Einband: Taschenbuch
• Anzahl der Seiten: 414
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Deutschland