Pediatric Non-Clinical Drug Testing

Principles, Requirements, and Practice

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
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Author: ISBN: 9781118168257
Publisher: Wiley Publication: December 28, 2011
Imprint: Wiley Language: English
Author:
ISBN: 9781118168257
Publisher: Wiley
Publication: December 28, 2011
Imprint: Wiley
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

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