Genotoxic Impurities: Strategies for Identification

Editorial Reviews
Review
"This is a very good book and addresses the issue in a very sensible, dare I say it, pragmatic approach." (The British Toxicology Society Joual, 1 May 2011)
"Overall, a valuable addition to a pharmaceutical scientists' library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts and programme managers. I can recommend it." (Joual of Organic Process Research & Development, 2011)
"The style throughout is easy to read and content readily digested, especially those chapters [on] chemical process development and early-phase API development .. From a more practical point of view, the contents are well set out, and indexing appeared appropriate. .. Overall, a valuable addition to a pharmaceutical scientist's library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts, and programme managers. I can recommend it." (American Chemical Society, 2011)
Product Description
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 conce (TTC) and is followed byasection on safety aspects, including safety tests in vivo and vitro, and data interpretation.The second section addresses the risk posed Authorgenotoxic impurities fromoutside sources and from mutagenswithin 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.

Hardcover: 444 pages

Publisher: Wiley; 1 edition (March 1, 2011)

Language: English

ISBN-10: 0470499192

ISBN-13: 9780470499191
Product Dimensions: 9.4 x 6.4 x 1.2 inches
Shipping Weight: 1.8 pounds (View shipping rates and policies)
Average Customer Review: 5.0 out of 5 starsSee all reviews(2 customer reviews)