Overview

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 GTIs
• Provides an overview of the latest FDA and EMEA guidelines
• Explains the how and why of various GTI control tactics and practices
• Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing
• Includes real-life examples of GTI control in drug substance and drug product development processes

Full Product Details

9781322618692

Table of Contents

Reviews

Author Information

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.

Tab Content 6

Customer Reviews

Recent Reviews

Countries Available