Pediatric non-clinical drug testing (Record no. 71901)

MARC details
000 -LEADER
fixed length control field 03699nam a2200433 a 4500
001 - CONTROL NUMBER
control field EBC818510
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20240120133021.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m o d |
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cn|||||||||
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 111018s2012 njua sb 000 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
Canceled/invalid LC control number 2011043323
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9780470448618 (cloth)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118168264 (electronic bk.)
035 ## - SYSTEM CONTROL NUMBER
System control number (MiAaPQ)EBC818510
035 ## - SYSTEM CONTROL NUMBER
System control number (Au-PeEL)EBL818510
035 ## - SYSTEM CONTROL NUMBER
System control number (CaPaEBR)ebr10630570
035 ## - SYSTEM CONTROL NUMBER
System control number (CaONFJC)MIL362025
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)823731502
040 ## - CATALOGING SOURCE
Original cataloging agency MiAaPQ
Transcribing agency MiAaPQ
Modifying agency MiAaPQ
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RM301.25
Item number .P43 2012
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.7/040287
Edition number 23
245 00 - TITLE STATEMENT
Title Pediatric non-clinical drug testing
Medium [electronic resource] :
Remainder of title principles, requirements, and practice /
Statement of responsibility, etc. edited by Alan M. Hoberman, Elise M. Lewis.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Hoboken, N.J. :
Name of publisher, distributor, etc. John Wiley & Sons,
Date of publication, distribution, etc. 2012.
300 ## - PHYSICAL DESCRIPTION
Extent xv, 339 p. :
Other physical details ill.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 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.
520 ## - SUMMARY, ETC.
Summary, etc. "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.
533 ## - REPRODUCTION NOTE
Type of reproduction Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug development
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pediatric pharmacology
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pediatrics
Geographic subdivision United States
General subdivision Formulae, receipts, prescriptions
-- Safety measures.
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Hoberman, Alan M.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Lewis, Elise M.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element ProQuest (Firm)
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="https://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=818510">https://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=818510</a>
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