Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載


Development and Validation of Analytical Methods

簡體網頁||繁體網頁

Development and Validation of Analytical Methods pdf epub mobi 著者簡介


Development and Validation of Analytical Methods pdf epub mobi 圖書描述

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6-12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載

Development and Validation of Analytical Methods pdf epub mobi 圖書目錄




點擊這裡下載
    


想要找書就要到 本本書屋
立刻按 ctrl+D收藏本頁
你會得到大驚喜!!

發表於2024-12-23

Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載

Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載

Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載



喜欢 Development and Validation of Analytical Methods 電子書 的读者还喜欢


Development and Validation of Analytical Methods pdf epub mobi 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
出版者:Lightning Source Inc
作者:Riley, Christopher M. (EDT)/ Rosanske, Thomas W. (EDT)
出品人:
頁數:364
譯者:
出版時間:1996-6
價格:$ 117.52
裝幀:HRD
isbn號碼:9780080427928
叢書系列:

圖書標籤:  


Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載
想要找書就要到 本本書屋
立刻按 ctrl+D收藏本頁
你會得到大驚喜!!

Development and Validation of Analytical Methods pdf epub mobi 用戶評價

評分

評分

評分

評分

評分

Development and Validation of Analytical Methods 2024 pdf epub mobi 電子書 下載


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 onlinetoolsland.com All Rights Reserved. 本本書屋 版權所有