Pediatric Drug Development: Concepts and Applications

Drawing from years of experience in pediatric medicine, Andrew Mulberg, Senior Director of Clinical Research & Development, Johnson and Johnson, LLC felt there was an unmet need for a textbook devoted to an understanding of the issues surrounding development of pharmaceutical-based therapies in pediatric drug development. As an outgrowth of this passion for pediatric medicine, he set out to complete the first comprehensive book detailing the concepts and applications of pediatric drug development.

Today, the product of his work and his passion has yielded his second publication, entitled, Pediatric Drug Development: Concepts and Applications published by Wiley Blackwell. Created in collaboration with Steve A. Silber, Vice President of Established Products at J&JPRD and John van den Anker, Professor of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC and many of his J&JPRD/academic/ government colleagues, Pediatric Drug Development: Concepts and Applications was designed as both a reference and a textbook.

The publication explores the scientific differences between the pediatric and the adult subject in the development of medicines, while taking into account the ethics and medical needs of pediatric patients. In addition, the book examines the overarching business case for the proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a successful program. The book aims to provide the information necessary to ensure better and safer drugs for pediatric patients.

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