Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載


Development and Approval of Combination Products

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Development and Approval of Combination Products pdf epub mobi 圖書描述

A step-by-step, integrated approach for successful, FDA-approved combination drug products

Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are:

* The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products

* Approaches to clinical trial protocol design and execution

* Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products

* Key sponsor/FDA meetings and negotiations essential for approval and commercialization

Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes.

This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載

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發表於2024-11-13

Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載

Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載

Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載



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出版者:
作者:Siegel, Evan B. 編
出品人:
頁數:216
譯者:
出版時間:2008-5
價格:687.00元
裝幀:
isbn號碼:9780470050941
叢書系列:

圖書標籤: 工具類  醫療   


Development and Approval of Combination Products 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 Approval of Combination Products pdf epub mobi 用戶評價

評分

亮點是幾個章節中有的case study,尤其是Exubera,其他的草草翻過

評分

亮點是幾個章節中有的case study,尤其是Exubera,其他的草草翻過

評分

亮點是幾個章節中有的case study,尤其是Exubera,其他的草草翻過

評分

亮點是幾個章節中有的case study,尤其是Exubera,其他的草草翻過

評分

亮點是幾個章節中有的case study,尤其是Exubera,其他的草草翻過

Development and Approval of Combination Products 2024 pdf epub mobi 電子書 下載


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