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100   $a20100617d2010      uy         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aGenotoxic impurities $estrategies for identification and control /$fedited by Andrew Teasdale
205   $a1st ed.
210   $aHoboken, N.J. $cJohn Wiley & Sons$d2010
215   $a1 online resource (445 p.)
300   $aDescription based upon print version of record.
311   $a0-470-49919-2 
320   $aIncludes bibliographical references and index.
327   $aGENOTOXIC 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
327   $aCHAPTER 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
327   $aCHAPTER 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
327   $aCHAPTER 15: ASPECTS TO CONSIDER WHEN LOW - LEVEL ACTIVE PHARMACEUTICAL INGREDIENT/DRUG PRODUCT DEGRADANTS HAVE THE POTENTIAL FOR GENOTOXICITYINDEX; Colour plate
330   $aThis 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
606   $aGenetic toxicology
606   $aDrugs$xToxicology
615  0$aGenetic toxicology.
615  0$aDrugs$xToxicology.
676   $a616/.042
701   $aTeasdale$b Andrew$0915395
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910139192803321
996   $aGenotoxic impurities$92051914
997   $aUNINA