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虫号: 148874
注册: 2005-12-28
专业: 药剂学

[交流] 药品国际注册 International Pharmaceutical Registration（转）

【所属专业】：Chemistry/Pharmaceutics
【文档大小】：34MB/pdf
中/英文名称:药品国际注册 / International Pharmaceutical Registration
出版商: CRC; Ringbound edition
发行时间: June 1, 2000
语言： English
页数：872pages
大小：3.5 x 11.5 x 11.5 inches
价格: $299.95
ISBN:1574911031
编/作者: Alan A. Chalmers
简介: http://www.amazon.com/Internatio ... ie=UTF8&s=books
http://www.pharmaceuticalnetbase ... ary/toc.asp?id=1422
International Pharmaceutical Registration has been prepared in response to numerous requests to provide a practical overview and guide to the complexities of pharmaceutical registration internationally. With the increasing globalisation of pharmaceutical markets and continuing consolidation within the pharmaceutical industry, the challenges of rapidly evolving regulatory requirements, including the opportunities presented by increased harmonisation of regulatory guidelines in ternationally have forged a much greater appreciation of the need for regulatory awareness.
Individual country chapters are written by national experts from regulatory authorities, international pharmaceutical companies and regulatory consultants. This was an intentional approach to emphasise the partnership involved in regulatory affairs between the regulators and the industry in the spirit of cooperation as reflected in such endeavours as the International Conference on Harmonisation (ICH). Whereas the ICH has focused on the major centres of pharmaceutical research and development, namely the European Union (EU), Japan and the United States, which led to many harmonised guidelines covering these areas (and recognised also in many other countries), the wider international pharmaceutical regulatory world remains much more diverse.

Contents
• Australia
• Belgium and Luxembourg
• Brazil
• Bulgaria
• Canada
• European Union
• France
• Germany
• Gulf States
• Hungary
• India
• Ireland
• Israel
• Japan
• Korea
• Malaysia
• Netherlands
• New Zealand
• Nigeria
• Poland
• Portugal
• Russia
• Singapore
• Slovak Republic
• South Africa
• Switzerland
• Thailand
• Tunisia
• Turkey
• Ukraine
• United Kingdom
• United States

封面:

是在Ivanhk提供的版本上完善的。

下载
http://rapidshare.de/files/36435 ... gistration.rar.html

(Click the picture to see the source)

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