Genotoxic impurities : strategies for identification and control /

• Άλλοι συγγραφείς: Teasdale, Andrew
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : Wiley, [2010]
• Θέματα: Genetic toxicology.; Drugs > Toxicology.; Mutagenicity Tests > methods.; Drug Toxicity > prevention & control.; Mutagens > adverse effects.; Mutagens > analysis.; Toxicogenetics > methods.; HEALTH & FITNESS > Diseases > Genetic.; MEDICAL > Genetics.; Electronic books.

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...

Πίνακας περιεχομένων:

• 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.