Pediatric non-clinical drug testing
Subtitle: principles, requirements, and practice
By: edited by Alan M. Hoberman, Elise M. Lewis
Publisher: John Wiley & Sons
Published: 2011
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470448618
Subjects: Age Factors; Child; Infant; Animal Models; Drug Toxicity; Preclinical Drug Evaluation; Prevention & control; Drug Approval
Description: "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.
Notes: Includes bibliographical references.
Table of contents: title: Machine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, Timothy P. Coogan; title: Overview of pediatric diseases and clinical considerations on developing medicines for children / Bert Suys, Jose Ramet; title: Nonclinical safety assessment for biopharmaceuticals : challenges and strategies for juvenile animal testing / Timothy P. Coogan; title: FDA approach to pediatric testing / Robert E. Osterberg; title: Pediatric drug development plans / Kimberly Brennan, Beatriz Silva Lima; title: Application of principles of nonclinical pediatric drug testing to the hazard evaluation of environmental contaminants / Susan L. Makris; title: Nonclinical testing procedures - pharmacokinetics / Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert; title: Preclinical development of a pharmaceutical product for children / Graham P. Bailey, Timothy P. Coogan, Luc M. De Schaepdrijver; title: Juvenile toxicity study design for the rodent and rabbit / Alan M. Hoberman, and John Barnett Jr.; title: Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau; title: Use of the swine pediatric model / Paul C. Barrow; title: Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.]; title: Use of primate pediatric model / Gerhard F. Weinbauer; title: Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec.