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Genotoxic impurities : strategies for identification and control / / edited by Andrew Teasdale
| Genotoxic impurities : strategies for identification and control / / edited by Andrew Teasdale |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, 2010 |
| Descrizione fisica | 1 online resource (445 p.) |
| Disciplina | 616/.042 |
| Altri autori (Persone) | TeasdaleAndrew |
| Soggetto topico |
Genetic toxicology
Drugs - Toxicology |
| ISBN |
0-470-93475-1
1-283-91604-5 0-470-92937-5 0-470-92936-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910139192803321 |
| Hoboken, N.J., : John Wiley & Sons, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
ICH quality guidelines : an implementation guide / / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA
| ICH quality guidelines : an implementation guide / / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2018 |
| Descrizione fisica | 1 online resource (722 pages) : illustrations (some color) |
| Disciplina | 615.19 |
| Soggetto topico |
Drug development
Drugs - Testing Drugs - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-118-97113-2
1-118-97112-4 1-118-97114-0 |
| Classificazione | MED071000TEC032000SCI013060 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910271046603321 |
| Hoboken, New Jersey : , : Wiley, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
ICH quality guidelines : an implementation guide / / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA
| ICH quality guidelines : an implementation guide / / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2018 |
| Descrizione fisica | 1 online resource (722 pages) : illustrations (some color) |
| Disciplina | 615.19 |
| Soggetto topico |
Drug development
Drugs - Testing Drugs - Quality control |
| ISBN |
1-118-97113-2
1-118-97112-4 1-118-97114-0 |
| Classificazione | MED071000TEC032000SCI013060 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910830215403321 |
| Hoboken, New Jersey : , : Wiley, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale
| Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022] |
| Descrizione fisica | 1 online resource (547 pages) |
| Disciplina | 576.542 |
| Soggetto topico |
Drugs - Testing
Mutagenicity testing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-55126-9
1-119-55125-0 1-119-55124-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910555183803321 |
| Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale
| Mutagenic impurities : strategies for identification and control / / edited by Andrew Teasdale |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022] |
| Descrizione fisica | 1 online resource (547 pages) |
| Disciplina | 576.542 |
| Soggetto topico |
Drugs - Testing
Mutagenicity testing |
| ISBN |
1-119-55126-9
1-119-55125-0 1-119-55124-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Historical perspective on the development of the EMEA Guideline and subsequent ICH M7 Guideline -- ICH M7 -assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk -- Control strategies for mutagenic impurities -- Use of structure-activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities -- Evolution of quantitative structure-activity relationships ((Q)SAR) for mutagenicity -- Toxicity testing to understand the mutagenicity of pharmaceutical impurities -- Compound- and class-specific limits for common impurities in pharmaceuticals -- Genotoxic threshold mechanisms and points of departure -- Mutagenic impurities -assessment of fate and control options -- N-nitrosamines -- Conditions potentially leading to the formation of mutagenic impurities -- Strategic approaches to the chromatographic analysis of mutagenic impurities -- Analysis of mutagenic impurities by nuclear magnetic resonance (NMR) spectroscopy -- Addressing the complex problem of degradation-derived mutagenic impurities in drug substances and products. |
| Record Nr. | UNINA-9910831035503321 |
| Hoboken, New Jersey : , : John Wiley & Sons, Incorporated, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||