| 查看: 454 | 回复: 0 | |||||
| 当前主题已经存档。 | |||||
[资源]
Handbook of Stability Testing in Pharmaceutical Development
|
|||||
|
Kim Huynh-Ba, "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices" 895845 | 2008 | ISBN: 0387856269 | 328 pages | PDF | 4,9 MB A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include: * Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. * Post-approval considerations and regulatory filing strategies to support a global supply chain. * Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. * Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. * Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). * USP-NF testing in support of stability. * Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. * Discussion of matrixing and bracketing to support reduced stability testing. * Overview of stability programs for biologics and drug-in-devices pharmaceutical products. This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines. http://depositfiles.com/en/files/0yghgztz3 http://uploading.com/files/4E0GCY19/StabilitTesting.zip.html http://www.megaupload.com/?d=DORPI0AZ |
回复此楼» 收录本帖的淘帖专辑推荐
 制剂书籍 | 药物制剂研发 |
» 猜你喜欢
40+中年人失业后，还能找到好工作吗？
已经有11人回复
-
用NBS溴化时溶剂除了CCl4外还有什么
已经有6人回复
-
申请科研项目纯靠实力能成功吗？
已经有11人回复
-
极限拉扯，如何抉择
已经有15人回复
-
二审4个多月了还是Awaiting Reviewer Scores
已经有4人回复
-
OpenAI又攻克数学难题了，离AI做有机合成还有多远？
已经有13人回复
-
课题组会帮你通过考核么？
已经有7人回复
-
售一区SCI文章T0P，我:8O.551.O54,科目全,可十急
已经有9人回复
-
售SCI一区T0P文章，我:8.O55.1.O.54,科目全,可十急
已经有8人回复
-
售SCI一区文章，我:8O5.5.1.O5.4,科目全,可伽急
已经有10人回复
200