Genotoxic Impurities : Strategies for Identification and Control.
Title:
Genotoxic Impurities : Strategies for Identification and Control.
Author:
Teasdale, Andrew.
ISBN:
9780470929360
Personal Author:
Edition:
1st ed.
Physical Description:
1 online resource (445 pages)
Contents:
GENOTOXIC IMPURITIES: Strategies for Identification and Control -- CONTENTS -- FOREWORD -- PREFACE -- CONTRIBUTORS -- PART 1: DEVELOPMENT OF GENOTOXIC IMPURITIES GUIDELINES AND THE THRESHOLD OF TOXICOLOGICAL CONCERN CONCEPT -- CHAPTER 1: HISTORICAL OVERVIEW OF THE DEVELOPMENT OF GENOTOXIC IMPURITIES GUIDELINES AND THEIR IMPACT -- CHAPTER 2: DEVELOPMENT OF THE THRESHOLD OF TOXICOLOGICAL CONCERN CONCEPT AND ITS RELATIONSHIP TO DURATION OF EXPOSURE -- PART 2: EVALUATION OF GENOTOXIC RISK FROM A PRECLINICAL PERSPECTIVE -- CHAPTER 3: GENETIC TOXICITY TESTING TO QUALIFY ALERTING IMPURITIES -- CHAPTER 4: USE OF STRUCTURE ACTIVITY RELATIONSHIP ( SAR ) EVALUATION AS A CRITICAL TOOL IN THE EVALUATION OF THE GENOTOXIC POTENTIAL OF IMPURITIES -- CHAPTER 5: COMPOUND - SPECIFIC RISK ASSESSMENTS FOR GENOTOXIC IMPURITIES: EXAMPLES AND ISSUES -- CHAPTER 6: HUMAN GENOTOXIC METABOLITES: IDENTIFICATION AND RISK MANAGEMENT -- PART 3: PERSPECTIVE ON RISK POSED BY GENOTOXIC IMPURITIES -- CHAPTER 7: GENOTOXIC THRESHOLDS -- CHAPTER 8: GENOTOXIC IMPURITIES: A RISK IN PERSPECTIVE -- PART 4: ASSESSMENT OF GENOTOXIC RISK: QUALITY PERSPECTIVE -- CHAPTER 9: STRATEGIES FOR THE EVALUATION OF GENOTOXIC IMPURITY RISK -- CHAPTER 10: ANALYSIS OF GENOTOXIC IMPURITIES: REVIEW OF APPROACHES -- CHAPTER 11: DEVELOPMENT OF A STRATEGY FOR ANALYSIS OF GENOTOXIC IMPURITIES -- CHAPTER 12: STRATEGIC APPROACHES TO THE CHROMATOGRAPHIC ANALYSIS OF GENOTOXIC IMPURITIES -- CHAPTER 13: ANALYSIS OF GENOTOXIC IMPURITIES BY NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY -- CHAPTER 14: MECHANISM AND PROCESSING PARAMETERS AFFECTING THE FORMATION OF SULFONATE ESTERS: SUMMARY OF THE PRODUCT QUALITY RESEARCH INSTITUTE STUDIES -- CHAPTER 15: ASPECTS TO CONSIDER WHEN LOW - LEVEL ACTIVE PHARMACEUTICAL INGREDIENT/DRUG PRODUCT DEGRADANTS HAVE THE POTENTIAL FOR GENOTOXICITY -- INDEX -- Colour plate.
Abstract:
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.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Genre:
Electronic Access:
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