Genotoxic Impurities: Strategies for Identification and Control

Genotoxic Impurities: Strategies for Identification and Control

by Andrew Teasdale
     
 

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This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An

Overview

This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

Editorial Reviews

From the Publisher
“This book is a valuable resource when dealing with genotoxic impurities. Its publication is timely considering the new ICH M7 guideline under discussion. I highly recommend the book to toxicology and CMC professionals and to anyone with a general interest in genotoxic impurities.”  (Drug Information Journal, 1 March 2012)

"This is an unmatched resource for understanding current regulations that guide the development of pharmaceuticals with respect to genotoxic substances, including the foundational principles upon which these guidelines were established. Armed with this knowledge, readers will appreciate the assessment of analytical techniques to control genotoxic impurities to a level that preserves both drug safety and quality throughout the development process." (Doody's, 26 August 2011)

"This is a very good book and addresses the issue in a very sensible, dare I say it, pragmatic approach." (The British Toxicology Society Journal, 1 May 2011)

"Overall, a valuable addition to a pharmaceutical scientists' library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts and programme managers. I can recommend it." (Journal of Organic Process Research & Development, 2011)

"The style throughout is easy to read and content readily digested, especially those chapters [on] chemical process development and early-phase API development ... From a more practical point of view, the contents are well set out, and indexing appeared appropriate. ... Overall, a valuable addition to a pharmaceutical scientist's library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts, and programme managers. I can recommend it." (American Chemical Society, 2011)

Doody's Review Service
Reviewer: Rachel R Chennault, PhD (American College of Clinical Pharmacy)
Description: This book sets out a realistic approach to understanding the challenges in meeting current regulatory guidelines surrounding genotoxic impurities in the drug development and manufacturing process.
Purpose: Determining and controlling the levels of potentially genotoxic impurities of pharmaceuticals to safe thresholds are significant components of drug development, yet uncertainty about the formal regulatory guidelines challenges their implementation. As a result, this book reviews these current guidelines in detail and leads readers through practical steps to analyze and evaluate the risks of genotoxic impurities.
Audience: Quality and safety issues arise in the consideration of genotoxic impurities. As such, the chapters of this book are authored by highly qualified experts in both of these fields. The book is intended to serve an audience of individuals from industry and regulatory sectors alike. Interestingly, controversy surrounding the implementation of strict impurity controls during drug development in light of the degree to which people are exposed to genotoxic substances from natural sources is likely to stimulate dialogue among researchers from a broader range of scientific disciplines.
Features: The book begins with a historical perspective of the development of formalized regulatory guidelines for genotoxic impurities, emphasizing the need for continued dialogue to resolve the remaining ambiguity about implementing these guidelines. The subsequent focus turns to the analytical and safety strategies and technical methods for assessing genotoxic impurity risk and controlling levels to a safe dose that reduces this risk.
Assessment: This is an unmatched resource for understanding current regulations that guide the development of pharmaceuticals with respect to genotoxic substances, including the foundational principles upon which these guidelines were established. Armed with this knowledge, readers will appreciate the assessment of analytical techniques to control genotoxic impurities to a level that preserves both drug safety and quality throughout the development process.

Product Details

ISBN-13:
9780470934753
Publisher:
Wiley
Publication date:
03/29/2011
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
444
File size:
10 MB

What People are saying about this

From the Publisher
“This book is a valuable resource when dealing with genotoxic impurities. Its publication is timely considering the new ICH M7 guideline under discussion. I highly recommend the book to toxicology and CMC professionals and to anyone with a general interest in genotoxic impurities.” (Drug Information Journal, 1 March 2012)

"This is an unmatched resource for understanding current regulations that guide the development of pharmaceuticals with respect to genotoxic substances, including the foundational principles upon which these guidelines were established. Armed with this knowledge, readers will appreciate the assessment of analytical techniques to control genotoxic impurities to a level that preserves both drug safety and quality throughout the development process." (Doody's, 26 August 2011)

"This is a very good book and addresses the issue in a very sensible, dare I say it, pragmatic approach." (The British Toxicology Society Journal, 1 May 2011)

"Overall, a valuable addition to a pharmaceutical scientists' library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts and programme managers. I can recommend it." (Journal of Organic Process Research & Development, 2011)

"The style throughout is easy to read and content readily digested, especially those chapters [on] chemical process development and early-phase API development ... From a more practical point of view, the contents are well set out, and indexing appeared appropriate. ... Overall, a valuable addition to a pharmaceutical scientist's library. The topics covered are relevant and of interest to various ‘stake-holders' in the drug development arena, including chemists, analysts, and programme managers. I can recommend it." (American Chemical Society, 2011)

Meet the Author

ANDREW TEASDALE, PhD, is a senior QA executive with AstraZeneca and chairs the company's internal genotoxic impurities advisory group. With over fifteen years of experience in analytical chemistry and quality assurance, Dr. Teasdale has published a number of papers relating to GIs and has been a speaker on genotoxic impurities at a number of conferences. Dr. Teasdale has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control.

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