Pediatric non-clinical drug testing : principles, requirements, and practice

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...

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Bibliographic Details
Other Authors: Hoberman, Alan M. (-), Lewis, Elise M.
Format: eBook
Language:Inglés
Published: Hoboken, N.J. : John Wiley & Sons 2012.
Subjects:
Drug development > United States.
Pediatric pharmacology > United States.
Pediatrics > United States > Formulae, receipts, prescriptions > Safety measures.
Electronic books.
Online Access:https://recursos.uloyola.es/login?url=https://accedys.uloyola.es:8443/accedix0/sitios/ebook.php?id=179200
See on Universidad Loyola - Universidad Loyola Granada:https://colectivo.uloyola.es/Record/ELB179200
Request an interlibrarian loan: Email
Description
Summary:"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.
Physical Description:xv, 339 p. : ill
Bibliography:Includes bibliographical references.
ISBN:9781118168264

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