Analysis of genotoxic Impurities
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EMEA guideline – Control of Genotoxic Impurities
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FDA guideline
Genetic Toxicity
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
Genotoxic Degradants
Genotoxic Impurities
Genotoxic Metabolites
Threshold of Toxicological Concern
Product details
- ISBN 9780470499191
- Weight: 758g
- Dimensions: 163 x 241mm
- Publication Date: 15 Feb 2011
- Publisher: John Wiley & Sons Inc
- Publication City/Country: US
- Product Form: Hardback
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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.
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.
