Gebundenes Buch

Pharmaceutical Industry Practices on Genotoxic Impurities

Beschreibung

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists. This book strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, practices, and case studies from the pharmaceutical industry. Exploring the safety, quality, and regulatory aspects of GTIs, the text explains the how and why of various GTI control tactics and practices, including GTI control examples in drug substance and drug product development processes from large and small pharmaceutical firms in multiple geographical regions.

Autor

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.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 536
• Erscheinungstermin: 4. September 2014
• Englisch
• Abmessung: 234mm x 155mm x 33mm
• Gewicht: 885g
• ISBN-13: 9781439874202
• ISBN-10: 1439874204
• Artikelnr.: 38022315