24小时热门版块排行榜

>论坛更新日志 (3210)
>虫友互识 (1163)
>导师招生 (265)
>论文道贺祈福 (179)
>高分子 (80)
>硕博家园 (56)
>学术会议 (41)
>论文投稿 (36)
>休闲灌水 (35)
>招聘信息布告栏 (32)
>找工作 (31)
>考博 (29)
>博后之家 (25)
>考研 (22)
>公派出国 (14)
>教师之家 (13)

返回列表

当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖

llb1978

金虫 (正式写手)

应助: 2 (幼儿园)
金币: 1364.2
红花: 2
帖子: 462
在线: 24.7小时
虫号: 92998
注册: 2005-09-12
性别: GG
专业: 药物学

[交流] 【取消求助】求International Pharmaceutical Product Registration, 2nd pdf电子书已有5人参与

https://catalogue.informahealthc ... roduct-Registration,-Second-Edition-ISBN-9781420081763,%201420081764;jsessionid=B6934F95EBB1E32C8F430D70306C4DC4
Listed in: Pharmaceutical & Biotechnology

International Pharmaceutical Product Registration, Second Edition
Series: Drugs and the Pharmaceutical Sciences
Anthony Cartwright (Pharmaceutical Regulatory Consultant, Harpenden, UK)
Brian R. Matthews (Alcon Laboratories, Hemel Hempstead, UK)
Book
Pub Date September 2009 Edition Second Series Drugs and the Pharmaceutical Sciences Volume 200 Pages 856 Size 7 x 10 ISBN 9781420081763, 1420081764 Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.

The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.

This resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also discussed.

The book is organized into six practical segments:

• CTD, eCTD, Module 1, and Environmental Risk Assessment
• CTD Summaries
• Quality Topics
• Nonclinical Topics
• Clinical Topics
• Other Topics, such as drug-device combination products
谢谢高手帮忙。

[ Last edited by llb1978 on 2011-5-26 at 11:57 ]

回复此楼