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...
| Автор-организации: | ebrary, Inc. |
|---|---|
| Други автори: | Hoberman, Alan M., Lewis, Elise M. |
| Формат: | Електронен |
| Език: | English |
| Публикувано: |
Hoboken, N.J. :
John Wiley & Sons,
2012.
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| Предмети: | |
| Онлайн достъп: |
An electronic book accessible through the World Wide Web; click to view |
Съдържание:
- Machine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, Timothy P. Coogan
- Overview of pediatric diseases and clinical considerations on developing medicines for children / Bert Suys, Jose Ramet
- Nonclinical safety assessment for biopharmaceuticals : challenges and strategies for juvenile animal testing / Timothy P. Coogan
- FDA approach to pediatric testing / Robert E. Osterberg
- Pediatric drug development plans / Kimberly Brennan, Beatriz Silva Lima
- Application of principles of nonclinical pediatric drug testing to the hazard evaluation of environmental contaminants / Susan L. Makris
- Nonclinical testing procedures - pharmacokinetics / Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert
- Preclinical development of a pharmaceutical product for children / Graham P. Bailey, Timothy P. Coogan, Luc M. De Schaepdrijver
- Juvenile toxicity study design for the rodent and rabbit / Alan M. Hoberman, and John Barnett Jr.
- Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau
- Use of the swine pediatric model / Paul C. Barrow
- Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.]
- Use of primate pediatric model / Gerhard F. Weinbauer
- Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec.