Pediatric non-clinical drug testing : principles, requirements, and practice / edited by Alan M. Hoberman, Elise M. Lewis.
"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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| Online Access: |
Full Text (via ProQuest) |
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| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley & Sons,
2012.
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| Subjects: |
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.