Download e-book Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice

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  1. Download Pediatric Nonclinical Drug Testing Principles Requirements And Practices;
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Display Non-Printed Markup Elements. Enhanced Content - Developer Tools. In addition to toxicologists and pharmacokineticists, this book is recommended for drug regulators who need to develop and enforce drug testing standards to protect children. It is also recommended as a textbook for toxicology and pediatric medicine courses.

2016, v.30(01) 13-20

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. Read more Read less. Amazon Global Store US International products have separate terms, are sold from abroad and may differ from local products, including fit, age ratings, and language of product, labeling or instructions. Manufacturer warranty may not apply Learn more about Amazon Global Store.

Review "Overall, this is a very useful book in bringing together many of the aspects associated with JA toxicology testing of pharmaceuticals for the first time, especially for those new to this growing field, with the chapters on study design considerations being especially useful. Introduction 1 Elise M. Lewis, Luc M.

De Schaepdrijver, and Timothy P. Coogan 2.

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Elise Lewis, Author at eureka

Coogan 4. Osterberg 5. Brannen and Beatriz Silva Lima 6. Makris 7. Annaert 8. De Schaepdrijver 9.


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