Includes bibliographical references and index.
Due to license restrictions, this resource is available to EPA employees and authorized contractors only

chapter 1. Overview of regulatory guidelines on impurities and genotoxic impurities / Heewon Lee and Debie Hoivik -- chapter 2. Structural alerts for genotoxicity and carcinogenicity / Heewon Lee -- chapter 3. Acceptable exposure calculations for impurities and selected compounds from the carcinogenic potency database / Heewon Lee -- chapter 4. Genotoxic impurities from toxicology perspectives including cancer risk assessment, in silico, in vitro/in vivo testings, and regulatory aspects / Esther Vock -- chapter 5. In silico/computational assessment for the evaluation of genotoxic impurities / Alexander Amberg, Andreas Czich, and V?ronique Thybaud -- chapter 6. Preclinical assessment of genotoxic impurities an overview of current regulatory guidance, available assays, and data interpretation / Todd J. Page, Vincent L. Reynolds, and J. Barry Phelps -- chapter 7. Purification of lead compounds for early toxicology profiling such as Ames and short-term non-GLP (good laboratory practice) toxicology tests / Zheng Hua, Wesley W. Barnhart, and Kyung H. Gahm -- chapter 8. Analysis of genotoxic impurities in pharmaceuticals by gas chromatography-mass spectrometry / Jie Zheng and Adam P. Schellinger -- chapter 9. Control of chloroethane in raw materials and drug substances using headspace/gas chromatography analysis / Johanna Ubben and Bing-Shiou Yang -- chapter 10. Quantification of genotoxic impurities in active pharmaceutical ingredients / Roy Helmy, Sophie Strickfuss, Mohammad Al-Sayah, Simon Hamilton, Xiaodong Bu, Claire Lee, Tiebang Wang, and Christopher Welch -- chapter 11. Analytical testing and control for genotoxic impurities in drug substances / Jane Li and Larry Wigman -- chapter 12. Approaches to assess, analyze, and control genotoxic impurities in drug substance development / Heewon Lee -- chapter 13. Control and analysis of genotoxic impurities in drug substance development / Zhi Chen, Jianbing Zhang, Shan Xiao, Qin Ji, and Frances Liu -- chapter 14. Salt formation of pharmaceutical compounds and associated genotoxic risks / Soojin Kim -- chapter 15. Identification and control of genotoxic degradation products / Fenghe Qiu -- chapter 16. Identification and qualification of genotoxic impurities as leachables in drug products / Douglas J. Ball, William P. Beierschmitt, Krista L. Dobo, and Cynthia J. Magee -- chapter 17. Pharmaceutical industry survey on genotoxic impurities and related topics / William A. Yakush and Heewon Lee. "A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text:Explores the safety, quality, and regulatory aspects of GTIsProvides an overview of the latest FDA and EMEA guidelinesExplains the how and why of various GTI control tactics and practicesDescribes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testingIncludes real-life examples of GTI control in drug substance and drug product development processesContaining case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of and a current framework for GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines"--