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关键词:
Drug Safety Evaluation, 3Rd Edition
书目信息
ISBN:
9781119097396
本馆索书号:
中图分类号:
R9
中文译名:
作者:
Shayne Cox Gad
编者:
语种:
英语
出版信息
出版社:
Wiley
出版地:
出版年:
2016
版本:
版本类型:
原版
丛书题名:
卷期:
文献信息
关键词:
前言:
摘要:
This new edition of Drug Safety Evaluation is a complete revision that also maintains the central objective of its predecessors, presenting an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. The many changes in the scope of products (small synthetic, large protein moieties and cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks have required both extensive revision to every chapter and the addition of a number of new chapters. They address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (including carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems.
内容简介:
目次:
全文链接:
http://www.itextbook.cn/f/book/bookDetail?bookId=55a7fa1529334a98aca0972c5c73b7bb
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