Book description
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. 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.
