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Genotoxic Impurities
Andrew . Ed(S): Teasdale
€ 172.57
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Description for Genotoxic Impurities
This book provides a primary reference point for anyone addressing the issue of genotoxic impurities, providing not only a definitive narrative of regulatory guidelines but also practical solutions to effectively manage the issue. Specific sections examine this from both a toxicological and analytical perspective. Editor(s): Teasdale, Andrew. Num Pages: 444 pages, Illustrations. BIC Classification: MFN; PN. Category: (P) Professional & Vocational. Dimension: 243 x 156 x 29. Weight in Grams: 804.
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 ... Read more
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 ... Read more
Product Details
Publication date
2011
Publisher
John Wiley and Sons Ltd United States
Number of pages
444
Condition
New
Number of Pages
448
Format
Hardback
Place of Publication
New York, United States
ISBN
9780470499191
SKU
V9780470499191
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-1
About Andrew . Ed(S): Teasdale
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 ... Read more
Reviews for Genotoxic Impurities
“This book is a valuable resource when dealing with genotoxic impurities. Its publication is timely considering the new ICH M7 guideline under discussion. I highly recommend the book to toxicology and CMC professionals and to anyone with a general interest in genotoxic impurities.” (Drug Information Journal, 1 March 2012) "This is an unmatched resource for understanding current regulations ... Read more