Genotoxic impurities : strategies for identification and control /

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...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Άλλοι συγγραφείς: Teasdale, Andrew
Μορφή: Ηλ. βιβλίο
Γλώσσα:English
Έκδοση: Hoboken, N.J. : Wiley, [2010]
Θέματα:
Διαθέσιμο Online:Full Text via HEAL-Link
LEADER 04980nam a2200745 4500
001 ocn698591455
003 OCoLC
005 20170124072621.9
006 m o d
007 cr mn|||||||||
008 100617s2010 njua ob 001 0 eng d
010 |z  2010025374 
040 |a E7B  |b eng  |e pn  |c E7B  |d OCLCQ  |d OSU  |d OCLCQ  |d IDEBK  |d OCLCF  |d DKDLA  |d OCLCQ  |d DG1  |d EBLCP  |d YDXCP  |d N$T  |d UKDOC  |d NLGGC  |d DEBSZ  |d OCLCQ  |d COO  |d OCLCQ  |d DEBBG  |d AZK  |d GrThAP 
019 |a 701311237  |a 705868750  |a 961561954  |a 962625401 
020 |a 9780470929360  |q (electronic bk.) 
020 |a 0470929367  |q (electronic bk.) 
020 |a 9780470929377  |q (electronic bk.) 
020 |a 0470929375  |q (electronic bk.) 
020 |z 9780470499191  |q (cloth) 
020 |z 0470499192  |q (cloth) 
024 7 |a 10.1002/9780470929377  |2 doi 
029 1 |a AU@  |b 000049641632 
029 1 |a AU@  |b 000053277681 
029 1 |a DEBBG  |b BV041911174 
029 1 |a DEBSZ  |b 430945906 
029 1 |a DKDLA  |b 820120-katalog:000557206 
029 1 |a NZ1  |b 14255775 
029 1 |a DEBBG  |b BV043392700 
035 |a (OCoLC)698591455  |z (OCoLC)701311237  |z (OCoLC)705868750  |z (OCoLC)961561954  |z (OCoLC)962625401 
037 |a 10.1002/9780470929377  |b Wiley InterScience  |n http://www3.interscience.wiley.com 
050 4 |a RA1224.3  |b .G463 2010eb 
060 4 |a QU 450  |b G3353 2011 
072 7 |a HEA  |x 039060  |2 bisacsh 
072 7 |a MED  |x 107000  |2 bisacsh 
082 0 4 |a 616/.042  |2 22 
049 |a MAIN 
245 0 0 |a Genotoxic impurities :  |b strategies for identification and control /  |c edited by Andrew Teasdale. 
264 1 |a Hoboken, N.J. :  |b Wiley,  |c [2010] 
264 4 |c ©2010 
300 |a 1 online resource (xii, 428 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
347 |a data file  |2 rda 
380 |a Bibliography 
504 |a Includes bibliographical references and index. 
588 0 |a Print version record. 
505 0 |a 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. 
520 |a 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. T. 
650 0 |a Genetic toxicology. 
650 0 |a Drugs  |x Toxicology. 
650 2 |a Mutagenicity Tests  |x methods. 
650 2 |a Drug Toxicity  |x prevention & control. 
650 2 |a Mutagens  |x adverse effects. 
650 2 |a Mutagens  |x analysis. 
650 2 |a Toxicogenetics  |x methods. 
650 7 |a HEALTH & FITNESS  |x Diseases  |x Genetic.  |2 bisacsh 
650 7 |a MEDICAL  |x Genetics.  |2 bisacsh 
650 7 |a Drugs  |x Toxicology.  |2 fast  |0 (OCoLC)fst00898958 
650 7 |a Genetic toxicology.  |2 fast  |0 (OCoLC)fst00940097 
655 4 |a Electronic books. 
700 1 |a Teasdale, Andrew. 
776 0 8 |i Print version:  |t Genotoxic impurities.  |d Hoboken, N.J. : Wiley, ©2010  |z 9780470499191  |w (DLC) 2010025374  |w (OCoLC)643443212 
856 4 0 |u https://doi.org/10.1002/9780470929377  |z Full Text via HEAL-Link 
994 |a 92  |b DG1