Pediatric non-clinical drug testing : principles, requirements, and practice /

"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 ho...

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Bibliographic Details
Other Authors:	Hoberman, Alan M., Lewis, Elise M.
Format:	eBook
Language:	English
Language Notes:	English.
Published:	Hoboken, N.J. : John Wiley & Sons, 2012.
Subjects:	Drug development > United States. Pediatric pharmacology > United States. Pediatrics > United States > Formulae, receipts, prescriptions > Safety measures. Age factors in disease. Children. Infants. Drug Evaluation, Preclinical Drug-Related Side Effects and Adverse Reactions > prevention & control Age Factors Child Drug Approval Infant Models, Animal United States
Online Access:	Connect to the full text of this electronic book

Table of Contents:

Pediatric Nonclinical Drug Testing; Contents; Preface; Acknowledgments; Contributors; 1. Introduction; 2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children; 3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing; 4. FDA Approach to Pediatric Testing; 5. Pediatric Drug Development Plans; 6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants; 7. Nonclinical Testing Procedures--Pharmacokinetics.
8. Preclinical Development of a Pharmaceutical Product for Children9. Juvenile Toxicity Study Design for the Rodent and Rabbit; 10. Dog Juvenile Toxicity; 11. Use of the Swine Pediatric Model; 12. Juvenile Immunodevelopment in Minipigs; 13. Use of Primate Pediatric Model; 14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective; Appendix 1 Maturation of Organ Systems in Various Species; Appendix 2 Sample Juvenile Toxicity Testing Protocol; Index.