| 000 | 05394cam a2200841Ma 4500 | ||
|---|---|---|---|
| 001 | ocn698591455 | ||
| 003 | OCoLC | ||
| 005 | 20171224113554.0 | ||
| 006 | m o d | ||
| 007 | cr mn||||||||| | ||
| 008 | 100617s2010 njua ob 001 0 eng d | ||
| 010 | _z 2010025374 | ||
| 040 |
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| 019 |
_a701311237 _a705868750 _a961561954 _a962625401 |
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| 020 |
_a9780470929360 _q(electronic bk.) |
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| 020 |
_a0470929367 _q(electronic bk.) |
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| 020 |
_a9780470929377 _q(electronic bk.) |
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| 020 |
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| 020 |
_z9780470499191 _q(cloth) |
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| 020 |
_z0470499192 _q(cloth) |
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| 024 | 7 |
_a10.1002/9780470929377 _2doi |
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| 029 | 1 |
_aAU@ _b000049641632 |
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| 029 | 1 |
_aAU@ _b000053277681 |
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_aDEBBG _bBV041911174 |
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_aNZ1 _b14255775 |
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_aDEBBG _bBV043392700 |
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| 035 |
_a(OCoLC)698591455 _z(OCoLC)701311237 _z(OCoLC)705868750 _z(OCoLC)961561954 _z(OCoLC)962625401 |
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| 037 |
_a10.1002/9780470929377 _bWiley InterScience _nhttp://www3.interscience.wiley.com |
||
| 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 |
| 049 | _aMAIN | ||
| 245 | 0 | 0 |
_aGenotoxic impurities : _bstrategies for identification and control / _cedited by Andrew Teasdale. |
| 260 |
_aHoboken, N.J. : _bWiley, _c©2010. |
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| 300 |
_a1 online resource (xii, 428 pages) : _billustrations |
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| 336 |
_atext _btxt _2rdacontent |
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| 337 |
_acomputer _bc _2rdamedia |
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| 338 |
_aonline resource _bcr _2rdacarrier |
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| 347 |
_adata file _2rda |
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| 380 | _aBibliography | ||
| 504 | _aIncludes bibliographical references and index. | ||
| 588 | 0 | _aPrint version record. | |
| 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. | ||
| 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 |
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| 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 |
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