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20210419.0 |
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170601s2015 flu eng |
| 020 |
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|a 9781439874202
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|a UniSZA
|e rda
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|a RA1224.3
|b .P43 2015
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1 |
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|a QU550.5.M8
|b P536 2015
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|a RA1224.3
|b .P43 2015
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| 245 |
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|a Pharmaceutical industry practices on genotoxic impurities
|c edited by Heewon Lee
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| 264 |
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1 |
|a Boca Raton, Florida :
|b CRC Press
|c c2015
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| 300 |
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|a Vol. 107, xviii, 517 pages ;
|c 24 cm.
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| 336 |
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|a text
|2 rdacontent
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| 337 |
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|a unmediated
|2 rdamedia
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| 338 |
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|a volume
|2 rdacarrier
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| 490 |
1 |
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|a Chromatographic science series
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| 504 |
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|a Includes bibliographical references and index
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| 505 |
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|a 1. Overview of regulatory guidelines on impurities and genotoxic impurities -- 2. Structural alerts for genotoxicity and carcinogenicity -- 3. Acceptable exposure calculations for impurities and selected compounds from the carcinogenic potency database -- 4. Genotoxic impurities from toxicology perspectives including cancer risk assessment, in silico, in vitro/in vigo testings, and regulatory aspects -- 5. In silico/computational assessment for the evaluation of genotoxic impurities -- 6.Preclinical assessment of genotoxic impurities an overview of current regulatroy guidance, available assays, and data interpretation -- 7. Purification of lead compounds for early toxicology profiling sucs as ames and short-term non-GLP (good laboratory practice) toxicology tests -- 8. Analysis of genotoxic impurities in pharmaceutical by gas chromatography-mass spectromatry -- 9. Control of chloroethane in raw materials and drug substances using headspace/gas chromatograghy analysis -- 10. Quantification of genotoxic impurities in active pharmaceutical ingredients -- 11. Analytical testing and control for genotoxic impurities in drug substances -- 12. Approaches to assess, analyze, and control genotoxic impurities in drug substance development -- 13. Control and analysis of genotoxic impurities in drug substance development -- 14. Salt formation of pharmaceutical compounds and associated genotoxic risks -- 15. Identification and control of genotoxic degradation products -- 16. Identifical and qualification of genotoxic impurities as leachables in drug products -- 17. Pharmaceutical industry survey on genotoxic impurities and related topics
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| 650 |
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|a Drugs
|x Toxicology
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| 650 |
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0 |
|a Genetic toxicology
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| 650 |
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0 |
|a Mutagenicity Tests
|x Methods
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| 650 |
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0 |
|a Mutagens
|x Adverse effects
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| 650 |
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0 |
|a Mutagens
|x Toxicity
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| 700 |
1 |
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|a Lee, Heewon ,
|e author
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| 856 |
4 |
2 |
|3 Cover image
|u http://images.tandf.co.uk/common/jackets/websmall/978143987/9781439874202.jpg
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| 999 |
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|a 1000169261
|b Book
|c OPEN SHELF (30 DAYS)
|e Tembila Campus
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