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...

Descripción completa

Detalles Bibliográficos
Otros Autores: Hoberman, Alan M. (-), Lewis, Elise M.
Formato: Libro electrónico
Idioma:Inglés
Publicado: Hoboken, N.J. : John Wiley & Sons 2012.
Materias:
Drug development > United States.
Pediatric pharmacology > United States.
Pediatrics > United States > Formulae, receipts, prescriptions > Safety measures.
Electronic books.
Acceso en línea:https://recursos.uloyola.es/login?url=https://accedys.uloyola.es:8443/accedix0/sitios/ebook.php?id=179200
Ver en Universidad Loyola - Universidad Loyola Granada:https://colectivo.uloyola.es/Record/ELB179200
Solicitar por préstamo interbibliotecario: Correo
Tabla de Contenidos:
  • 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.

Ejemplares similares