Genotoxic Impurities: Strategies for Identification and ControlISBN: 978-0-470-49919-1
Hardcover
444 pages
March 2011
This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 15-20 days delivery time. The book is not returnable.
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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.