Fundamentals of Pediatric Drug Dosing

Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. 

With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.

1. Pediatric Drug Development and the Regulatory Changes that are Creating the Science of Pediatric Dosing.- 2. Pediatric Physiology.- 3. Developmental Pharmacology: Impact on Pharmacokinetics and Pharmacodynamics of Drugs.- 4. Pediatric Clinical Trial Design and Dosing.- 5. Applicaton of Allometric Principles in Pediatric Drug Development.- 6. Population Pharmacokinetics in Pediatric Drug Development.- 7. Scaling Dose-Exposure-Response from Adults to Children.- 8. Applications of Physiologically-Based Pharmacokinetic (PBPK) Models for Pediatric Populations.- 9. Perinatal Pharmacology and Maternal/Fetal Dosing.

Iftekhar Mahmood, Ph. D., is a clinical Pharmacologist at the Center for Biologic Evaluation and Research (CBER), FDA.  He holds a Bachelor of Pharmacy degree and a Ph.D. degree in Pharmaceutical Sciences with specialization in pharmacokinetics.  Dr. Mahmood joined the FDA in December 1993 and for more than 8 years served as a clinical pharmacologist dealing with neuro-pharmacology products in Center for Drug Evaluation and Research (CDER). Since last 10 years, Dr. Mahmood has been a clinical pharmacologist for therapeutic proteins and blood products.  Dr. Mahmood is involved in several CBER and CDER working groups. Dr. Mahmood has published more than 100 scientific papers in peer-reviewed scientific journals.  He is author of the books “Interspecies Pharmacokinetic Scaling”, “Pediatric Pharmacology and Pharmacokinetics”, and “Pharmacokinetic Allometric Scaling in Pediatric Drug Development”. Dr. Mahmood is the recipient of several CDER Intramural Research Grants as well as the recipient of several CDER and CBER awards.

Division of Hematology Clinical Review Branch, Office of Blood Review & Research (OBRR), Center for Biologics Evaluation and Research, Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.

Dr. Gilbert Burckart is presently Associate Director for Pediatrics, Office of Clinical Pharmacology, U.S. Food and Drug Administration.  Dr. Burckart received his B.S. in Pharmacy from the University of Pittsburgh in 1972, his Pharm.D. from the University of Kentucky in 1975, and did his pediatric residency at University of Kentucky in Lexington and Norton Children’s Hospital in Louisville.  He served on the faculties of the State University of New York at Buffalo at Buffalo Children’s Hospital, the University of Tennessee at LeBonheur Children’s Hospital, and the University of Pittsburgh and the Pittsburgh Children’s Hospital.  In 2003, he moved to the University of Southern California in Los Angeles, where he was Chairman of the Department of Pharmacy, and Professor of Pharmacy and Professor of Pediatrics.

Dr. Burckart has previously served as the President of the American College of Clinical Pharmacy, and as President of the American College of Clinical Pharmacology.

Dr. Burckart moved to the US FDA in 2008.  His duties include participation in the FDA’s Pediatric Review Committee.