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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...
| Clasificación: | Libro Electrónico |
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| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
John Wiley & Sons,
2012.
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| Temas: | |
| Acceso en línea: | Texto completo |
| Sumario: | "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"--Provided by publisher. |
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| Descripción Física: | 1 online resource (xv, 339 pages) : illustrations |
| Bibliografía: | Includes bibliographical references. |
| ISBN: | 9781118168264 1118168267 047044861X 9780470448618 9781118168257 1118168259 9781118168226 1118168224 9786613620255 6613620254 |