反馈文件质量
lgli/G:\!genesis\_add\wiley\Nonclinical Safety Assessment.pdf
Nonclinical safety assessment : a guide to international pharmaceutical regulations 🔍
William J. Brock, Kenneth L. Hastings, Kathy McGown, Kathy M. McGown Wiley & Sons, Incorporated, John, 1, 2013
英语 [en] · PDF · 13.7MB · 2013 · 📘 非小说类图书 · 🚀/duxiu/lgli/lgrs/nexusstc/zlib · Save
描述
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
备用文件名
lgrsnf/G:\!genesis\_add\wiley\Nonclinical Safety Assessment.pdf
备用文件名
nexusstc/Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations/2282824770afe8c656c5f5549f6ea7e5.pdf
备用文件名
zlib/no-category/William J Brock; Kenneth L Hastings/Nonclinical safety assessment : a guide to international pharmaceutical regulations_2362075.pdf
备选标题
Nonclinical Safety Assessment:A Guide to International Pharmaceutical Regulations,Brock, William,Wiley [Imprint];John Wiley & Sons, Incorporated,,,,
备选作者
William Brock, Kenneth Hastings, Kathy M. McGown, William J. Brock, Kenneth L. Hastings
备选作者
edited by William J. Brock, Kenneth L. Hastings, and Kathy McGown
备选作者
Brock, William J.; Hastings, Kenneth L.; McGown, Kathy M.
备选作者
Kenneth L Hastings; William J Brock
备用出版商
John Wiley & Sons, Incorporated
备用出版商
Wiley & Sons, Limited, John
备用出版商
John Wiley & Sons, Ltd
备用出版商
Spectrum Publications
备用出版商
Halsted Press
备用版本
John Wiley & Sons, Inc., Chichester, West Sussex, 2013
备用版本
United States, United States of America
备用版本
Chichester, West Sussex, England, 2013
备用版本
Chichester, UK, 2013
备用版本
Hoboken, 2013
元数据中的注释
lg1193662
元数据中的注释
{"edition":"1","isbns":["0470745916","1118517008","1118517016","9780470745915","9781118517000","9781118517017"],"last_page":487,"publisher":"Wiley"}
元数据中的注释
Includes bibliographical references and index.
备用描述
Content: Introduction to the development of drugs / Kathy McGown --
ICH / Ken Hastings --
USFDA / Bill Brock --
Latin America : MERCOSUR countries / Cristiana Leslie Corra --
Canada / Mark T. Goldberg --
EMEA / Adam Woolley --
Africa / Fariza Feraoun --
China / Lijie Fu --
Japan / Kazuichi Nakamura --
India / K.S. Rao --
Australia / Doug Francis --
Chronic repeat dose testing / Shana Azri-Meehan --
Carcinogenicity / James Popp --
Genotoxicity / Mark Powley --
Developmental and reproductive toxicology / Robert Parker --
Juvenile testing and pediatric claim / Melissa Tassinari --
Immunotoxicology / Leigh Ann Burns Naas --
Biologics / Chris Ellis --
Vaccines / Robert House --
Phototoxicity and photocarcinogenicity / Chris Sambuco --
Degradants, impurities excipients, and metabolites / Bob Osterberg.
备用描述
Providing a comprehensive, international overview of the regulatory requirements for safety assessment for new drug approvals, each chapter in Nonclinical Safety Assessment is written by experts who have direct, firsthand involvement in drug development in the regions where they are located.
开源日期
2014-07-13
更多信息……

🚀 快速下载

成为会员以支持书籍、论文等的长期保存。为了感谢您对我们的支持，您将获得高速下载权益。❤️

🐢 低速下载

由可信的合作方提供。 更多信息请参见常见问题解答。 （可能需要验证浏览器——无限次下载！）

所有选项下载的文件都相同，应该可以安全使用。即使这样，从互联网下载文件时始终要小心。例如，确保您的设备更新及时。
显示外部下载
  • 对于大文件，我们建议使用下载管理器以防止中断。
    推荐的下载管理器：JDownloader
  • 您将需要一个电子书或 PDF 阅读器来打开文件，具体取决于文件格式。
    推荐的电子书阅读器：Anna的档案在线查看器、ReadEra和Calibre
  • 使用在线工具进行格式转换。
    推荐的转换工具：CloudConvert和PrintFriendly
  • 您可以将 PDF 和 EPUB 文件发送到您的 Kindle 或 Kobo 电子阅读器。
    推荐的工具：亚马逊的“发送到 Kindle”和djazz 的“发送到 Kobo/Kindle”
  • 支持作者和图书馆
    ✍️ 如果您喜欢这个并且能够负担得起，请考虑购买原版，或直接支持作者。
    📚 如果您当地的图书馆有这本书，请考虑在那里免费借阅。