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Mutagenic Impurities: Strategies for Identification and Control by Andrew Teasda
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所在地:Ohio, 美國
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- ISBN-13
- 9781119551218
- Book Title
- Mutagenic Impurities
- ISBN
- 9781119551218
- Publication Year
- 2021
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Publication Name
- Mutagenic Impurities: Strategies for Identification and Control
- Publisher
- John Wiley & Sons AND Sons LTD
- Subject
- Biology
- Item Weight
- 666g
- Number of Pages
- 560 Pages
關於產品
Product Information
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Product Identifiers
Publisher
John Wiley & Sons AND Sons LTD
ISBN-13
9781119551218
eBay Product ID (ePID)
27049955484
Product Key Features
Publication Name
Mutagenic Impurities: Strategies for Identification and Control
Format
Hardcover
Language
English
Subject
Biology
Publication Year
2021
Type
Textbook
Number of Pages
560 Pages
Dimensions
Item Weight
666g
Additional Product Features
Country/Region of Manufacture
United States
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商業賣家資料
增值稅識別編號:
- GB 324767388
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物品所在地:
Ohio, 美國
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全球
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免運費 | 免費 | 美國 | 標準運送方式 (Standard Int'l Postage) | 估計於 7月1日, 一至 7月5日, 五之間送達 運送地點 43230 |
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