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Teasdale, Andrew

Genotoxic Impurities: Strategies for Identification and Control

Teasdale, Andrew - Genotoxic Impurities: Strategies for Identification and Control, ebook

124,30€

Ebook, PDF with Adobe DRM
ISBN: 9780470929360
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Printing134 pages with an additional page accrued every 6 hours, capped at 134 pages
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This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2011
Language
en
Edition
1
Page amount
448 pages
Category
Medicine, Health Care, Mode
Format
Ebook
eISBN (PDF)
9780470929360
Printed ISBN
9780470499191

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