कवर छवि

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

अन्य संस्करण दिखाएं (1)

"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...

पूर्ण विवरण

में बचाया:
ग्रंथसूची विवरण
निगमित लेखक: ebrary, Inc
अन्य लेखक: Hoberman, Alan M., Lewis, Elise M.
स्वरूप: इलेक्ट्रोनिक ई-पुस्तक
भाषा:अंग्रेज़ी
प्रकाशित: Hoboken, N.J. : John Wiley & Sons, 2012.
विषय:
Drug development > United States.
Pediatric pharmacology > United States.
Pediatrics > United States > Formulae, receipts, prescriptions > Safety measures.
Electronic books.
ऑनलाइन पहुंच:An electronic book accessible through the World Wide Web; click to view
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विषय - सूची:
  • 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.

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