Pediatric Clinical Pharmacology (Handbook of Experimental Pharmacology, 205)

The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy. Front Matter....Pages i-xii Front Matter....Pages 1-1 Basics and Dynamics of Neonatal and Pediatric Pharmacology....Pages 3-49 Developmental Pharmacokinetics....Pages 51-75 Principles of Therapeutic Drug Monitoring....Pages 77-90 Drug Delivery and Formulations....Pages 91-107 Front Matter....Pages 109-109 Development of Paediatric Medicines: Concepts and Principles....Pages 111-124 Study Design and Simulation Approach....Pages 125-148 Efficacy Assessment in Paediatric Studies....Pages 149-168 Safety Assessment in Pediatric Studies....Pages 169-180 Small Sample Approach, and Statistical and Epidemiological Aspects....Pages 181-202 Sample Collection, Biobanking, and Analysis....Pages 203-217 Ethical Considerations in Conducting Pediatric Research....Pages 219-244 Pediatric Regulatory Initiatives....Pages 245-268 Front Matter....Pages 269-269 Fetal Medicine and Treatment....Pages 271-283 Fetal Risks of Maternal Pharmacotherapy: Identifying Signals....Pages 285-294 Antiepileptic Treatment in Pregnant Women: Morphological and Behavioural Effects....Pages 295-315 Preventive Medicines....Pages 317-337 Postmarketing Surveillance....Pages 339-351 Global Aspects of Drug Development....Pages 353-372 Back Matter....Pages 373-383 Reflecting increased cooperation between pediatricians and pharmacologists, this book surveys the state of the art of pediatric clinical pharmacology, including developmental physiology, pediatric-specific pathology, drug development and regulatory frameworks.