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010 _z 2010025374
020 _a9780470929360
_q(electronic bk.)
020 _a0470929367
_q(electronic bk.)
020 _a9780470929377
_q(electronic bk.)
020 _a0470929375
_q(electronic bk.)
020 _z9780470499191
_q(cloth)
020 _z0470499192
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024 7 _a10.1002/9780470929377
_2doi
029 1 _aAU@
_b000049641632
029 1 _aAU@
_b000053277681
029 1 _aDEBBG
_bBV041911174
029 1 _aDEBSZ
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029 1 _aNZ1
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035 _a(OCoLC)698591455
_z(OCoLC)701311237
_z(OCoLC)705868750
_z(OCoLC)961561954
_z(OCoLC)962625401
037 _a10.1002/9780470929377
_bWiley InterScience
_nhttp://www3.interscience.wiley.com
040 _aE7B
_beng
_epn
_cE7B
_dOCLCQ
_dOSU
_dOCLCQ
_dIDEBK
_dOCLCF
_dDKDLA
_dOCLCQ
_dDG1
_dEBLCP
_dYDXCP
_dN$T
_dUKDOC
_dNLGGC
_dDEBSZ
_dOCLCQ
_dCOO
_dOCLCQ
_dDEBBG
_dAZK
049 _aMAIN
050 4 _aRA1224.3
_b.G463 2010eb
060 4 _aQU 450
_bG3353 2011
072 7 _aHEA
_x039060
_2bisacsh
072 7 _aMED
_x107000
_2bisacsh
082 0 4 _a616/.042
_222
245 0 0 _aGenotoxic impurities : strategies for identification and control /
_cedited by Andrew Teasdale.
_h[electronic resource]
260 _aHoboken, N.J. :
_bWiley,
_c©2010.
300 _a1 online resource (xii, 428 pages) :
_billustrations
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _adata file
_2rda
380 _aBibliography
504 _aIncludes bibliographical references and index.
505 0 _aHistorical 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 _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. T.
588 0 _aPrint version record.
650 0 _aGenetic toxicology.
650 0 _aDrugs
_xToxicology.
650 2 _aMutagenicity Tests
_xmethods.
650 2 _aDrug Toxicity
_xprevention & control.
650 2 _aMutagens
_xadverse effects.
650 2 _aMutagens
_xanalysis.
650 2 _aToxicogenetics
_xmethods.
650 7 _aHEALTH & FITNESS
_xDiseases
_xGenetic.
_2bisacsh
650 7 _aMEDICAL
_xGenetics.
_2bisacsh
650 7 _aDrugs
_xToxicology.
_2fast
_0(OCoLC)fst00898958
650 7 _aGenetic toxicology.
_2fast
_0(OCoLC)fst00940097
655 4 _aElectronic books.
700 1 _aTeasdale, Andrew.
776 0 8 _iPrint version:
_tGenotoxic impurities.
_dHoboken, N.J. : Wiley, ©2010
_z9780470499191
_w(DLC) 2010025374
_w(OCoLC)643443212
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9780470929377
_zWiley Online Library
942 _2ddc
_cBK
999 _c204887
_d204887