Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice
Alan M. Hoberman, Elise M. Lewis
John Wiley & Sons, Dec 28, 2011 - Medical - 320 pages
This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.
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Overview of Pediatric Diseases and Clinical
Agency EMA Approach to Pediatric Testing
Application of Principles of Nonclinical Pediatric
Nonclinical Testing ProceduresPharmacokinetics
Preclinical Development of a Pharmaceutical
Use of the Swine Pediatric Model
Juvenile Immunodevelopment in Minipigs
Use of Primate Pediatric Model
Approaches to Rat Juvenile Toxicity Studies
antibody beagle behavior biopharmaceuticals Birth Defects Birth Defects Res body weight bone cells Charles River Laboratories clinical trials collected conducted cynomolgus monkey differences dosage dose Drug Administration drug development effects end points enzymes estrous cycling European Medicines Agency evaluation exposure female Food and Drug functional guidance hematology Historical Control Data human immune system juvenile animal studies juvenile animals juvenile studies juvenile toxicity studies juvenile toxicology Laboratories Preclinical Services litter male measurements Medicinal Products metabolism mg/kg/day minipig months of age necropsy neonatal nonclinical studies organ systems parameters pediatric drug development pediatric population pediatric studies pharmaceutical pharmacokinetic pharmacologic piglets postnatal postnatal development potential pups rabbits rats regulatory risk assessment River Laboratories Preclinical rodent safety Species comparison study design Subset Table target Teratology test article therapeutic tissues toxicity testing toxicokinetic Toxicol toxicology toxicology studies treatment weaning weeks of age