Handbook of Stability Testing in Pharmaceutical Development pdf epub mobi txt 電子書 下載 2024


Handbook of Stability Testing in Pharmaceutical Development

簡體網頁||繁體網頁
Huynh-Ba, Kim 編
2008-12
406
$ 236.17
9780387856261

圖書標籤:  


喜歡 Handbook of Stability Testing in Pharmaceutical Development 的讀者還喜歡




點擊這裡下載
    


想要找書就要到 小哈圖書下載中心
立刻按 ctrl+D收藏本頁
你會得到大驚喜!!

发表于2024-11-12

Handbook of Stability Testing in Pharmaceutical Development epub 下載 mobi 下載 pdf 下載 txt 電子書 下載 2024

Handbook of Stability Testing in Pharmaceutical Development epub 下載 mobi 下載 pdf 下載 txt 電子書 下載 2024

Handbook of Stability Testing in Pharmaceutical Development pdf epub mobi txt 電子書 下載 2024



圖書描述

This handbook is the first 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: (1) Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. (2) Post-approval considerations and regulatory filing strategies to support a global supply chain. (3) Methodologies, including development of a stability-indicating method, method validation and transfer. Physical stability, non-chromatographic methodologies, and spectroscopic applications are also discussed. (4) Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. (5) Data management, including stability reports, CMC and discussion of Out-of-Specification (OOS) and Out-of-Trend (OOT). (6) USP-NF testing in support of stability purposes. (7) Current industry best practices on stability operation, validation and calibration of stability chambers including considerations for photo-stability testing. (8) Discussion of matrixing and bracketing to support reduced stability testing. (9) 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.

Handbook of Stability Testing in Pharmaceutical Development 下載 mobi epub pdf txt 電子書

著者簡介


圖書目錄


Handbook of Stability Testing in Pharmaceutical Development pdf epub mobi txt 電子書 下載
想要找書就要到 小哈圖書下載中心
立刻按 ctrl+D收藏本頁
你會得到大驚喜!!

用戶評價

評分

評分

評分

評分

評分

讀後感

評分

評分

評分

評分

評分

類似圖書 點擊查看全場最低價

Handbook of Stability Testing in Pharmaceutical Development pdf epub mobi txt 電子書 下載 2024


分享鏈接





相關圖書




本站所有內容均為互聯網搜索引擎提供的公開搜索信息,本站不存儲任何數據與內容,任何內容與數據均與本站無關,如有需要請聯繫相關搜索引擎包括但不限於百度google,bing,sogou

友情鏈接

© 2024 qciss.net All Rights Reserved. 小哈圖書下載中心 版权所有