Pharmaceutical industry practices on genotoxic impurities

Title:

Series:

Chromatographic science series ; 107

Publication Information:

Boca Raton : CRC Press, Taylor & Francis Group, 2015

Physical Description:

xviii, 517 pages ; 24 cm.

ISBN:

9781439874202

Subject Term:

Genetic toxicology

Drugs -- Toxicology

Added Author:

Lee, Heewon,

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010340962	RA1224.3 P43 2015	Open Access Book	Book	Searching... Unknown

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

Containing 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.

Author Notes

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.

Heewon Lee and Debie HoivikHeewon LeeHeewon LeeEsther VockAlexander Amberg and Andreas Czich and Véronique ThybaudTodd J. Page and Vincent L. Reynolds and J. Barry PhelpsZheng Hua and Wesley W. Barnhart and Kyung H. GahmJie Zheng and Adam P. SchellingerJohanna Ubben and Bing-Shiou YangRoy Helmy and Sophie Strickfuss and Mohammad Al-Sayah and Simon Hamilton and Xiaodong Bu and Claire Lee and Tiebang Wang and Christopher WelchJane Li and Larry WigmanHeewon LeeZhi Chen and Jianbing Zhang and Shan Xiao and Qin Ji and Frances LiuSoojin KimFenghe QiuDouglas J. Ball and William P. Beierschmitt and Krista L. Dobo and Cynthia J. MageeWilliam A. Yakush and Heewon Lee

Preface	p. xiii
Editor	p. xv
List of Contributors	p. xvii
Chapter 1 Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities	p. 1
Chapter 2 Structural Alerts for Genotoxicity and Carcinogenicity	p. 65
Chapter 3 Acceptable Exposure Calculations for Impurities and Selected Compounds from the Carcinogenic Potency Database	p. 93
Chapter 4 Genotoxic Impurities from Toxicology Perspectives Including Cancer Risk Assessment, In Silico, In Vitro/In Vivo Testings, and Regulatory Aspects	p. 177
Chapter 5 In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities	p. 191
Chapter 6 Preclinical Assessment of Genotoxic Impurities An Overview of Current Regulatory Guidance, Available Assays, and Data Interpretation	p. 209
Chapter 7 Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Non-GLP (Good Laboratory Practice) Toxicology Tests	p. 235
Chapter 8 Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography-Mass Spectrometry	p. 255
Chapter 9 Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis	p. 279
Chapter 10 Quantification of Genotoxic Impurities in Active Pharmaceutical Ingredients	p. 293
Chapter 11 Analytical Testing and Control for Genotoxic Impurities in Drug Substances	p. 319
Chapter 12 Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development	p. 343
Chapter 13 Control and Analysis of Genotoxic Impurities in Drug Substance Development	p. 365
Chapter 14 Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks	p. 385
Chapter 15 Identification and Control of Genotoxic Degradation Products	p. 427
Chapter 16 Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products	p. 447
Chapter 17 Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics	p. 467
Index	p. 507

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Table of Contents