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.
Avainsanat: juvenile toxicity testing, EMEA legislation, Preclinical Safety Assessment, European Medicines Agency, EMEA, Pediatric Investigation Plan (PIP), FDA guidelines, Juvenile Animal Studies, non-clinical testing ethics, pediatric medicines, pediatric drug labeling, pediatric drug testing regulation, pharmaceutical development, pediatric pharmaceuticals, Historical Control Data, Pharmacology & Pharmaceutical Medicine, Anatomy & Physiology, Pharmacology & Pharmaceutical Medicine, Anatomy & Physiology