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Pediatric Drug Development and the Regulatory Changes That Are Creating the Science of Pediatric Dosing
Pages 1-12
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.
Pediatric Drug Development and the Regulatory Changes That Are Creating the Science of Pediatric Dosing
Pages 1-12
Pediatric Physiology
Pages 13-22
Developmental Pharmacology: Impact on Pharmacokinetics and Pharmacodynamics of Drugs
Pages 23-44
Pediatric Clinical Trial Design and Dosing
Pages 45-63
Application of Allometric Principles in Pediatric Drug Development
Pages 65-81
Population Pharmacokinetics in Pediatric Drug Development
Pages 83-92
Scaling Dose-Exposure-Response from Adults to Children
Pages 93-107
Applications of Physiologically Based Pharmacokinetic (PBPK) Models for Pediatric Populations
Pages 109-125
Perinatal Pharmacology and Maternal/Fetal Dosing
Pages 127-146
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