| 查看: 471 | 回复: 6 | ||
| 【奖励】 本帖被评价5次，作者lihai0910增加金币 5 个 | ||
| 当前主题已经存档。 | ||
[资源]
Validating Chromatographic Methods: A Practical Guide
|
||
|
Validating Chromatographic Methods: A Practical Guide David M. Bliesner ISBN: 978-0-471-74147-3 Hardcover 304 pages September 2006 Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems. Preface. 1. Overview of Methods Validation. 2. Components of Methods Validation. 3. Step 1: Method Evaluation and Further Method Development. 4. Step 2: Final Method Development and Trial Method Validation. 5. Step 3: Formal Method Validation and Report Generation. 6. Step 4: Formal Data Review and Report Issuance. Summary. Appendices. I. Glossary of Methods Validations Terms. II. Template for an Example Methods Validation Standard Operating Procedure (SOP). III. Template for an Example End-User Requirements Questionaire. IV. Template for an Example Method Review Checklist. V. Template for an Example Standard Test Method. VI. Template for an Example Methods Validation Protocol. VII. Template for an Example Methods Validation Report. References. Index. http://rapidshare.com/files/72583860/Validating_Chromatographic_Methods.zip [ Last edited by 佳怡 on 2009-4-23 at 21:28 ] |
回复此楼» 猜你喜欢
0854复试调剂 276
已经有5人回复
-
欢迎采矿、地质、岩土、计算机、人工智能等专业的同学报考
已经有6人回复
-
0857调剂
已经有5人回复
-
279求调剂
已经有4人回复
-
284求调剂
已经有8人回复
-
材料复试调剂
已经有4人回复
-
本子写完了，给DS兄弟看了，得了92分
已经有7人回复
-
求调剂
已经有6人回复
-
材料学硕318求调剂
已经有13人回复
-
一志愿郑大材料学硕298分，求调剂
已经有5人回复
2楼2007-12-15 14:26:11
3楼2007-12-24 07:20:40
5楼2008-02-13 13:00:03
简单回复
2008-02-08 22:37
回复
