Pediatric nonclinical drug testing : principles, requirements, and practices /

• Άλλοι συγγραφείς: Hoberman, Alan M., Lewis, Elise M.
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2012]
• Θέματα: Pediatric pharmacology > Research > United States.; Drugs > Toxicology > United States.; Drug Evaluation, Preclinical.; Age Factors.; Child.; Drug Approval.; Drug Toxicity > prevention & control.; Infant.; Models, Animal.; Läkemedelsutveckling.; United States.; Electronic books.

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 d...

Πίνακας περιεχομένων:

• Introduction / Elise M Lewis, Luc M De Schaepdrijver, Timothy P Coogan
• Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children / Bert Suys, Jose Ramet
• Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing / Timothy P Coogan
• FDA Approach to Pediatric Testing / Robert E Osterberg
• Pediatric Drug Development Plans / Kimberly C Brannen, Beatriz Silva Lima
• Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants / Susan L Makris
• Nonclinical Testing Procedures-Pharmacokinetics / Loeckie L de Zwart, Johan G Monbaliu, Pieter P Annaert
• Preclinical Development of a Pharmaceutical Product for Children / Graham P Bailey, Timothy P Coogan, Luc M De Schaepdrijver
• Juvenile Toxicity Study Design for the Rodent and Rabbit / Alan M Hoberman, John F Barnett
• Dog Juvenile Toxicity / Keith Robinson, Susan Y Smith, Andre Viau
• Use of the Swine Pediatric Model / Paul C Barrow
• Juvenile Immunodevelopment in Minipigs / Andre H Penninks, Geertje J D van Mierlo, Frieke Kuper, Cor J Snel, Niels-Christian Ganderup, Andre P M Wolterbeek
• Use of Primate Pediatric Model / Gerhard F Weinbauer, Gary J Chellman, Allan Dahl Rasmussen, Elvira Vogelwedde
• Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective / Susan B Laffan, Lorraine Posobiec
• Appendix 1: Maturation of Organ Systems in Various Species
• Appendix 2: Sample Juvenile Toxicity Testing Protocol.