Review of Genotoxic Impurities: Strategies for Identification and Control
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Review of Genotoxic Impurities: Strategies for Identification and Control
Teasdale A, ed. Genotoxic Impurities: Strategies for Identification and Control. Hoboken, NJ: John Wiley & Sons; 2010. Hardcover; 428 pages. ISBN: 978-0-470-49919-1 Reviewed by: Theresa Allio, PhD The Weinberg Group, Washington, DC, USA
The era of regulatory concern for genotoxic impurities represents a relatively recent period in the history of modern drug regulation, beginning in 2000 with an article on methane sulfonate impurities in mesilate salts1 followed by regulatory position papers2 and guidances3,4 on the topic. In 2007, a very real manufacturing incident involving the HIV drug Viracept raised new questions regarding the control of genotoxic impurities.5-9 In fact, identification and control of genotoxic impurities are such complicated issues that in 2010 an International Conference on Harmonization (ICH) process was initiated to develop a guidance solely dedicated to this topic (ICH M7).10 Genotoxic Impurities: Strategies for Identification and Control provides an excellent overview of genotoxic impurities and ways to consider them in risk assessment and manufacturing programs. This book contains information that would be of interest to toxicologists and to chemical, manufacturing, and controls (CMC) professionals, and it has the potential to become a trusted reference on the subject. The book is composed of 4 major sections. The first section provides the history and rationale for the current thinking on genotoxic impurities. The editor chose well in starting the book with the history of genotoxic impurity guideline development, as it can be easy to forget that guidelines are developed in multiple iterations. Updates are needed as more data and more people are included in the conversation. This section also emphasizes the complex challenges faced by today’s scientists given that a comprehensive and clear guidance is still under development. I would hope that after reading this book, more scientists consider becoming involved in the ICH process to ensure that a robust and useful guidance is developed. The method used to introduce the book’s topic sets an example that publications with similar content would do well to adopt. The second section of the book discusses ways to evaluate genotoxic risk from a preclinical perspective. This section provides hefty but easy to understand chapters on the use of
Drug Information Journal 46(2) 235-236 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512436582 http://dij.sagepub.com
structure activity relationship tools to identify impurities with a structural alert and the laboratory tests available to qualify these impurities. Real-life risk assessment examples are also included in this section. A chapter on how to ensure that human genotoxic metabolites are adequately covered in the nonclinical program is included. In sum, these chapters provide the reader with a sense of how to approach impurity evaluation and testing from initial ident
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