Genotoxic impurities : strategies for identification and control /

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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, thu...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Teasdale, Andrew
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2010.
Temas:
Genetic toxicology.
Drugs > Toxicology.
Mutagenicity Tests > methods
Drug-Related Side Effects and Adverse Reactions > prevention & control
Mutagens > adverse effects
Mutagens > analysis
Toxicogenetics > methods
Toxicologie génétique.
Médicaments > Toxicologie.
HEALTH & FITNESS > Diseases > Genetic.
MEDICAL > Genetics.
Drugs > Toxicology
Genetic toxicology
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Historical overview of the development of genotoxic impurities guidelines and their impact / R. Ogilvie, A. Teasdale
  • Development of the threshold of toxicological concern concept (TTC) and its relationship to duration of exposure / A. Brigo, L. Müller
  • Genetic toxicity testing to qualify alerting impurities / M. O'Donovan
  • Use of structure activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities / S. Glowienke, C. Hasselgren
  • Compound-specific risk assessments for genotoxic impurities : examples and issues / A. Teasdale, C. Humfrey
  • Human genotoxic metabolites : identification and risk / K. Dobo, D. Walker, A. Teasdale
  • Genotoxic thresholds / G. Jenkins [and others]
  • Genotoxic impurities : a risk in perspective? / D. Elder, J. Harvey
  • Strategies for the evaluation of genotoxic impurity risk / A Teasdale, S. Fenner, D. Elder
  • Analysis of genotoxic impurities : review of approaches / D. Elder
  • Development of a strategy for analysis of genotoxic impurities / Andrew Baker
  • Strategic approaches to the chromatographic analysis of genotoxic impurities / Frank David [and others]
  • Analysis of genotoxic impurities by nuclear magnetic resonance (NMR) spectroscopy / Andrew Philips
  • Mechanism and processing parameters affecting the formation of sulfonate esters : summary of the PQRI studies : PQRI working group / Andrew Teasdale
  • Aspects to consider when devising a strategy to understand if low level API/DP degradants have the potential for genotoxicity / Alan P. McKeown, Andrew Teasdale.

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