Pharmaceutical Industry Practices on Genotoxic Impurities

Preface

Editor

List of Contributors

Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities, Heewon Lee and Debie Hoivik

Structural Alerts for Genotoxicity and Carcinogenicity, Heewon Lee

Acceptable Exposure Calculations for Impurities and Selected Compounds from the Carcinogenic Potency Database, Heewon Lee

Genotoxic Impurities from Toxicology Perspectives Including Cancer Risk Assessment, In Silico, In Vitro/In Vivo Testings, and Regulatory Aspects, Esther Vock

In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities, Alexander Amberg, Andreas Czich, and Véronique Thybaud

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

Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Nongood Laboratory Practice Toxicology Tests, Zheng Hua, Wesley W. Barnhart, and Kyung H. Gahm

Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography–Mass Spectrometry, Jie Zheng and Adam P. Schellinger

Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis, Johanna Ubben and Bing-Shiou Yang

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

Analytical Testing and Control for Genotoxic Impurities in Drug Substances, Jane Li and Larry Wigman

Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development, Heewon Lee

Control and Analysis of Genotoxic Impurities in Drug Substance Development, Zhi Chen, Jianbing Zhang, Shan Xiao, Qin Ji, and Frances Liu

Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks, Soojin Kim

Identification and Control of Genotoxic Degradation Products, Fenghe Qiu

Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products, Douglas J. Ball, William P. Beierschmitt, Krista L. Dobo, and Cynthia J. Magee

Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics, William A. Yakush and Heewon Lee

Index

Biography

Heewon Lee is Senior Associate Director of the Chemical Development Department at Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA. She is also leader of the Analytical Research Group, an active participant in the Genotoxic Impurity Council, and a member of the Pharmaceutical IQ Consortium Working Group. She holds a BS and a MS from Seoul National University, South Korea, as well as a Ph.D from the University of Michigan, Ann Arbor, USA. Previously, she worked at ArQule, a biotechnology company located in Woburn, Massachusetts, USA. After ArQule, she joined the Medicinal Chemistry Department at Boehringer-Ingelheim before moving to her current position.