Pediatric Non-Clinical Drug Testing
Principles, Requirements, and Practice
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Beschreibung
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.
Autor*in
Alan M. Hoberman
Themen in »Pediatric Non-Clinical Drug Testing«
Anatomie u. Physiologie Anatomy & Physiology Biowissenschaften Chemie Chemistry Life Sciences Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin Toxicology Toxikologie Wirkstoffforschung
Stimmen zu »Pediatric Non-Clinical Drug Testing«
"Overall, this is a very useful book in bringing togethermany of the aspects associated with JA toxicology testing ofpharmaceuticals for the first time, especially for those new tothis growing field, with the chapters on study designconsiderations being especially useful." (BritishToxicology Society New, 1 November 2012)
"The book is an essential reference for internationalregulatory personnel, toxicologists, pharmacokineticists,scientists working in the pharmaceutical industry, academics andphysicians and pharmacists concerned about the safe use ofmedicines in children." (PharmaceuticalJournal, 11 September 2012)
"No other single resource combines pediatric drugdevelopment considerations with the most recent regulatoryrequirements and the approach to selecting and testing innonclinical models. This is a unique and comprehensive referencethat will inform and guide readers through the challenges andapproaches to the safe and effective use of medications inchildren." (Doody's, 17 August 2012)
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