Pediatric Drug Development: Concepts and Applications (v. 1)

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9780470169292: Pediatric Drug Development: Concepts and Applications (v. 1)
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Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

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The first comprehensive treatmentof this vital topic

For decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with "pediatric dosing" of drugs that were developed and intended for adults. Now, an awareness of the differences between the pediatric patient and the adult patient have begun to be realized and addressed by the pharmaceutical and wider healthcare industries, as well as the governmental and regulatory bodies that sanction the development and testing of drugs for children.

This is the first book to provide a comprehensive treatment of pediatric drug development. Written by a team of experts, it provides industry, academia, and governmental agencies with an understanding of how to properly develop drugs for children without compromising business objectives. The authors address the scientific differences between the pediatric and adult subject in the development of pharmaceutical products. They discuss and consider: ethics—from product concept to production; specific medical needs of children; business rationale for the proper development of drugs for children; and the technical feasibility of studies and processes that are necessary for a proper pediatric drug development program.

The book clearly explains the challenges and opportunities facing the entire healthcare community as it strives to improve the health of children worldwide. It demonstrates how these approaches will benefit all stakeholders and, ultimately, provide better and safer drugs for the pediatric population at large.

This timely new work is essential reading for academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in pediatric drug development. It also serves as an important textbook for students in pharmacy, science, and medicine courses.

About the Author:

Andrew E. Mulberg, MD, is Director of Pediatric Drug Development for Johnson and Johnson Pharmaceutical Research and Development, LLC, in Titusville, New Jersey, and is has been editor for four editions of the best-selling 5-Minute Pediatric Consult.

Steven A. Silber, MD, is Vice President for Drug Development and Safety with McNeil Pediatrics, Ortho-McNeil Women's Health and Urology, in Fort Washington, Pennsylvania.

John N. van den Anker, MD, PhD, is Executive Director of the Pediatric Pharmacology Research Unit and Director of Pediatric Clinical Pharmacology at the Children's National Medical Center, Washington, DC, and Professor of Pediatrics, Pharmacology and Physiology at George Washington University, Washington, DC, as well as an Adjunct Professor of Pediatrics at Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.

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