Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm - Couverture souple

Rose MD MS, Klaus

Couverture souple

ISBN 10 : 0128238887 ISBN 13 : 9780128238882

Editeur : Academic Press Inc, 2020

Synopsis

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.

A propos du livre

À propos de l'auteur

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.

Détails de l'édition

• Éditeur: Academic Press Inc
• Date d'édition: 2020
• Langue: anglais
• ISBN 10: 0128238887
• ISBN 13: 9780128238882
• Reliure: Broché
• Nombre de pages: 414
• Coordonnées du fabricant: Academic Press; https://shop.elsevier.com/; ; 230 PARK AVENUE, SUITE 800; NY; NY; 10169; Etats-Unis
• Personne responsable: Yeepin GmbH; 492000000000; sunshine12232@outlook.com; ; Alleestr.11; Kaiserslautern; Rheinland-Pfalz; 67655; Allemagne