Pediatric Drug Development: Concepts and Applications

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 inten [...]
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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.