| 查看: 276 | 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 |
回复此楼» 猜你喜欢
售SCI-T0P文章，我:8O.5.5.1.O.54,科目齐全,可+急
已经有13人回复
-
售SCI-T0P文章，我:8O.5.5.1.O.54,科目齐全,可+急
已经有18人回复
-
售SCI一区T0P文章，我:8.O.55.1.O.5.4,科目全,可+急
已经有18人回复
-
2027博士申请-临床检验诊断学、病原生物学、微生物方向
已经有4人回复
-
售SCI一区T0P文章，我:8.O.55.1.O.54,科目齐全,可+急
已经有10人回复
-
售SCI文章，我:8O.5.5.1O.54,科目全,可十急
已经有22人回复
-
越来越担心硕士毕业后没有竞争力了
已经有14人回复
-
论文的挂名怎么评判贡献？基金申请中，排名第一的挂名文章
已经有3人回复
-
申博自荐 2篇一区TOP+1篇EI+2公开发明专利 2027博士申请
已经有3人回复
-
闲聊
已经有6人回复