Can I read Pediatric Nonclinical Drug Testing: Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices on EtoBox?

Pediatric Nonclinical Drug Testing: Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices by Hoberman, Alan M. (editor);Lewis, Elise M. (editor) is a nonfiction available to read on EtoBox.

What is Pediatric Nonclinical Drug Testing: Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices about?

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.Content: Chapter 1 Introduction (pages 1–27): Elise M. Lewis, Luc M. De Schaepdrijver and Timothy P. Coogan Chapter 2 Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children (pages 29–39): Bert Suys and Jose Ramet Chapter 3 Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing (pages 41–57): Timothy P. Coogan Chapter 4 FDA Approach to Pediatric Testing (pages 59–77): Robert E. Osterberg Chapter 5 Pediatric Drug Development Plans (pages 79–92): Kimberly C. Bra

Who reads Pediatric Nonclinical Drug Testing: Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices?

Author

Hoberman, Alan M. (editor);Lewis, Elise M. (editor)

Publisher

John Wiley & Sons, Incorporated

Published

2012

Language

EN

ISBN

9781118168264

Category

nonfiction

Subjects

Medical, Medicine