Genotoxic Impurities: Strategies for Identification and Control - Hardcover

Hardcover

ISBN 10: 0470499192 ISBN 13: 9780470499191

Verlag: Wiley, 2011

Inhaltsangabe

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.

Über diesen Titel

Über die Autorin bzw. den Autor

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.

Von der hinteren Coverseite

A one-stop reference to genotoxic impurities in pharmaceuticals

This volume examines the full range of issues the pharmaceutical industry faces when seeking to ensure control over the levels of genotoxic impurities in pharmaceuticals. It offers comprehensive practical guidance on how to both assess and control genotoxic impurities (GIs) through all phases of drug development.

Featuring contributed chapters by experts from both the quality assurance and toxicology fields, Genotoxic Impurities covers all topics from the ground up, using real-world examples and case studies to help readers meet the challenges of regulatory compliance. Other important features include:

• A detailed review of current regulatory guidelines relating to GIs, including discussion of their implications and the thinking behind their development

• A thorough evaluation of the threshold of toxicological concern (TTC) concept, along with an examination of the emerging evidence supporting the existence of thresholds even for DNA-reactive mutagens.

• Step-by-step instructions , including both analytical and safety strategies, on how to evaluate risks posed by GIs

• Discussion of the risks posed by GIs from other sources, i.e., dietary exposure and the endogenous production of genotoxins.

• Specific advice on chromatographic strategy and other key analyticaltechniques, including the innovative use of NMR

The first comprehensive resource of its kind, Genotoxic Impurities is an indispensable reference for researchers and professionals in the pharmaceutical industry. It is also useful for regulatory professionals who need to interpret the regulatory guidelines covering GIs.

Aus dem Klappentext

A one-stop reference to genotoxic impurities in pharmaceuticals
 
This volume examines the full range of issues the pharmaceutical industry faces when seeking to ensure control over the levels of genotoxic impurities in pharmaceuticals. It offers comprehensive practical guidance on how to both assess and control genotoxic impurities (GIs) through all phases of drug development.
 
Featuring contributed chapters by experts from both the quality assurance and toxicology fields, Genotoxic Impurities covers all topics from the ground up, using real-world examples and case studies to help readers meet the challenges of regulatory compliance. Other important features include:
* A detailed review of current regulatory guidelines relating to GIs, including discussion of their implications and the thinking behind their development
* A thorough evaluation of the threshold of toxicological concern (TTC) concept, along with an examination of the emerging evidence supporting the existence of thresholds even for DNA-reactive mutagens.
* Step-by-step instructions , including both analytical and safety strategies, on how to evaluate risks posed by GIs
* Discussion of the risks posed by GIs from other sources, i.e., dietary exposure and the endogenous production of genotoxins.
* Specific advice on chromatographic strategy and other key analyticaltechniques, including the innovative use of NMR
 
The first comprehensive resource of its kind, Genotoxic Impurities is an indispensable reference for researchers and professionals in the pharmaceutical industry. It is also useful for regulatory professionals who need to interpret the regulatory guidelines covering GIs.

Details zur Ausgabe

• Verlag: Wiley
• Erscheinungsdatum: 2011
• Sprache: Englisch
• ISBN 10: 0470499192
• ISBN 13: 9780470499191
• Einband: Gebundene Ausgabe
• Auflage: 1
• Anzahl der Seiten: 448
• Herausgeber: Teasdale Andrew
• Kontakt zum Hersteller: Wiley-VCH GmbH; product_safety@wiley.com; ; Boschstrasse 12; Weinheim; 69469; Deutschland