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Genotoxic Impurities

Strategies for Identification and Control

Wiley, J,
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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.


Titel: Genotoxic Impurities
Autoren/Herausgeber: Andrew Teasdale (Hrsg.)
Ausgabe: 1. Auflage

ISBN/EAN: 9780470929360

Seitenzahl: 444
Produktform: E-Book
Sprache: Englisch

ANDREW TEASDALE, PhD, is a senior QA executive with AstraZeneca and chairs the company's internal genotoxic impurities advisory group. With over fifteen years of experience in analytical chemistry and quality assurance, Dr. Teasdale has published a number of papers relating to GIs and has been a speaker on genotoxic impurities at a number of conferences. Dr. Teasdale has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control. - Newsletter
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