The Resource Pediatric non-clinical drug testing : principles, requirements, and practice, edited by Alan M. Hoberman, Elise M. Lewis, (electronic resource)

Pediatric non-clinical drug testing : principles, requirements, and practice, edited by Alan M. Hoberman, Elise M. Lewis, (electronic resource)

Label
Pediatric non-clinical drug testing : principles, requirements, and practice
Title
Pediatric non-clinical drug testing
Title remainder
principles, requirements, and practice
Statement of responsibility
edited by Alan M. Hoberman, Elise M. Lewis
Contributor
Provider
Subject
Genre
Language
eng
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
Cataloging source
E7B
Illustrations
illustrations
Index
no index present
LC call number
RM301.25
LC item number
.P43 2012eb
Literary form
non fiction
Nature of contents
  • standards specifications
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
  • ebrary
  • Hoberman, Alan M
  • Lewis, Elise M
http://library.link/vocab/subjectName
  • Drug development
  • Pediatric pharmacology
  • Pediatrics
  • MEDICAL / Pharmacology
  • Drug Evaluation, Preclinical
  • Age Factors
  • Child
  • Drug Approval
  • Drug Toxicity
  • Infant
  • Models, Animal
  • Medical
Label
Pediatric non-clinical drug testing : principles, requirements, and practice, edited by Alan M. Hoberman, Elise M. Lewis, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references
Color
multicolored
Contents
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
Dimensions
unknown
Extent
1 online resource (xv, 339 p.)
Form of item
electronic
Isbn
9781118168257
Other control number
9786613620255
Other physical details
ill.
Publisher number
EB00062870
Specific material designation
remote
Stock number
362025
System control number
  • (OCoLC)823731502
  • (OCoLC)ocn823731502
Label
Pediatric non-clinical drug testing : principles, requirements, and practice, edited by Alan M. Hoberman, Elise M. Lewis, (electronic resource)
Publication
Bibliography note
Includes bibliographical references
Color
multicolored
Contents
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
Dimensions
unknown
Extent
1 online resource (xv, 339 p.)
Form of item
electronic
Isbn
9781118168257
Other control number
9786613620255
Other physical details
ill.
Publisher number
EB00062870
Specific material designation
remote
Stock number
362025
System control number
  • (OCoLC)823731502
  • (OCoLC)ocn823731502

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