Genotoxic impurities : strategies for identification and control / / edited by Andrew Teasdale

• Record Nr.: UNINA9910139192803321
• Pubbl/distr/stampa: Hoboken, N.J., : John Wiley & Sons, 2010
• ISBN: 0-470-93475-1; 1-283-91604-5; 0-470-92937-5; 0-470-92936-7
• Edizione: [1st ed.]
• Descrizione fisica: 1 online resource (445 p.)
• Altri autori (Persone): TeasdaleAndrew
• Disciplina: 616/.042
• Soggetti: Genetic toxicology; Drugs - Toxicology
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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 IMPURITIESCHAPTER 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 APPROACHESCHAPTER 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 GENOTOXICITYINDEX; Colour plate
• Sommario/riassunto: 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 ad