Guide to Paediatric Drug Development and Clinical Research

Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by pediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to pediatric needs, US and EU legislators have taken action, and the WHO has initiated a global pediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including pediatricians, pharmacists, general practitioners and health care professionals involved in childcare and pediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.