| 查看: 1106 | 回复: 7 | |||
| 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)
|
[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» 猜你喜欢
关于口服溶液剂药品上市后稳定性研究
已经有2人回复
-
FDA核查 研发机构
已经有1人回复
-
药理学论文润色/翻译怎么收费?
已经有295人回复
-
国家高层次人才李兴淑教授课题组招收博士研究生
已经有39人回复
-
己酮可可碱过氧化杂质限度
已经有2人回复
-
求助Isoeugenol质量标准
已经有0人回复
-
Gliclazide
已经有0人回复
-
塞替派/噻替哌（Thiotepa） 质量控制
已经有15人回复
-
有没有大佬可以帮忙查下Trijardy XR和Qternmet XR历年销售数据呀
已经有0人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 咨询投稿steel research international
已经有10人回复
fdaedqm
木虫 (正式写手)
- 应助: 4 (幼儿园)
- 金币: 3276.8
- 散金: 18
- 红花: 3
- 帖子: 443
- 在线: 69.1小时
- 虫号: 310078
- 注册: 2006-12-23
- 性别: GG
- 专业: 药物化学
7楼2011-05-09 11:56:20
3楼2010-11-23 19:36:22
wxy760428
铁杆木虫 (正式写手)
- 应助: 2 (幼儿园)
- 金币: 10242.2
- 散金: 35
- 红花: 1
- 帖子: 677
- 在线: 122.5小时
- 虫号: 190512
- 注册: 2006-02-20
- 专业: 药物化学
★
小木虫(金币+0.5):给个红包，谢谢回帖交流
小木虫(金币+0.5):给个红包，谢谢回帖交流
|
http://informahealthcare.com/doi/book/10.3109/9781420081831 可以下载电子版的，但我没有帐户权限 |
4楼2010-11-24 10:05:02
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
5楼2010-11-24 11:25:08