عنوان

Pediatric nonclinical drug testing :

شابک

047044861X (cloth)

شابک

9780470448618 (cloth)

شماره

dltt

عنوان اصلي

Pediatric nonclinical drug testing :

نام عام مواد

[Book]

ساير اطلاعات عنواني

principles, requirements, and practices /

نام نخستين پديدآور

edited by Alan M. Hoberman, Elise M. Lewis

نام خاص و کميت اثر

xv, 339 pages :

ساير جزييات

illustrations ;

ابعاد

25 cm

متن يادداشت

Includes bibliographical references and index

متن يادداشت

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

بدون عنوان

8

متن يادداشت

"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

عنوان اصلي به زبان ديگر

Pediatric non-clinical drug testing

موضوع مستند نشده

Drugs-- Toxicology-- United States

موضوع مستند نشده

Pediatric pharmacology-- Research-- United States

موضوع مستند نشده

Age Factors-- United States

موضوع مستند نشده

Child-- United States

موضوع مستند نشده

Drug Approval-- United States

موضوع مستند نشده

Drug Evaluation, Preclinical-- United States

موضوع مستند نشده

Drug Toxicity-- prevention & control-- United States

موضوع مستند نشده

Infant-- United States

موضوع مستند نشده

Models, Animal-- United States

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

شماره رده

مستند نام اشخاص تاييد نشده

Hoberman, Alan M

مستند نام اشخاص تاييد نشده

Lewis, Elise M

تاريخ عمليات

20160712083343.0

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y