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.

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.