Genotoxic Impurities

Beschreibung

This book examines genotoxic impurities and their impact on thepharmaceutical industry. Specific sections examine this fromboth a toxicological and analytical perspective. Within thesesections, the book defines appropriate strategies to both assessand ultimately control genotoxic impurities, thus aiding the readerto develop effective control measures. An opening section coversthe development of guidelines and the threshold of toxicologicalconcern (TTC) and is followed by a section on safetyaspects, including safety tests in vivo and vitro, and datainterpretation. The second section addresses the risk posed bygenotoxic impurities from outside sources and frommutagens within DNA. In the final section, the book dealswith the quality perspective of genotoxic impurities focused on twocritical aspects, the first being the analysis and the second howto practically evaluate the impurities.

Autor*in

Andrew Teasdale

Themen in »Genotoxic Impurities«

Analytical Chemistry Analytische Chemie Chemie Chemistry Drug Discovery & Development Toxicology Toxikologie Wirkstoffforschung u. -entwicklung

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"This book is a valuable resource when dealing withgenotoxic impurities. Its publication is timely considering the newICH M7 guideline under discussion. I highly recommend the book totoxicology and CMC professionals and to anyone with a generalinterest in genotoxic impurities." (Drug InformationJournal, 1 March 2012) "This is an unmatched resource for understanding currentregulations that guide the development of pharmaceuticals withrespect to genotoxic substances, including the foundationalprinciples upon which these guidelines were established. Armed withthis knowledge, readers will appreciate the assessment ofanalytical techniques to control genotoxic impurities to a levelthat preserves both drug safety and quality throughout thedevelopment process." (Doody's, 26 August 2011) "This is a very good book and addresses the issue in a verysensible, dare I say it, pragmatic approach." (The BritishToxicology Society Journal, 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, includingchemists, analysts and programme managers. I can recommend it."(Journal of Organic Process Research & Development, 2011) "The style throughout is easy to read and content readilydigested, especially those chapters [on] chemical processdevelopment and early-phase API development ... From a morepractical point of view, the contents are well set out, andindexing appeared appropriate. ... Overall, a valuable addition toa pharmaceutical scientist's library. The topics covered arerelevant and of interest to various 'stake-holders' in thedrug development arena, including chemists, analysts, and programmemanagers. I can recommend it." (American Chemical Society,2011)
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