| 000 | 03039nam a22004575i 4500 | ||
|---|---|---|---|
| 001 | 978-3-319-22084-0 | ||
| 003 | DE-He213 | ||
| 005 | 20160405112920.0 | ||
| 007 | cr nn 008mamaa | ||
| 008 | 151102s2015 gw | s |||| 0|eng d | ||
| 020 |
_a9783319220840 _9978-3-319-22084-0 |
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| 024 | 7 |
_a10.1007/978-3-319-22084-0 _2doi |
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| 050 | 4 | _aRC261-271 | |
| 072 | 7 |
_aMJCL _2bicssc |
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| 072 | 7 |
_aMED062000 _2bisacsh |
|
| 082 | 0 | 4 |
_a614.5999 _223 |
| 245 | 1 | 0 |
_aGenotoxicity and Carcinogenicity Testing of Pharmaceuticals _h[electronic resource] / _cedited by Michael J. Graziano, David Jacobson-Kram. |
| 250 | _a1st ed. 2015. | ||
| 264 | 1 |
_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2015. |
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| 300 |
_aX, 206 p. 15 illus., 8 illus. in color. _bonline resource. |
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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 |
_atext file _bPDF _2rda |
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| 505 | 0 | _aIntroduction -- History and Current Regulatory Requirements -- Genotoxicity Testing of API and Impurities -- New Emerging Genotoxicity Tests -- Carcinogenicity Testing of Small Molecules -- Alternatives to the 2-Year Rodent Studies -- Addressing Positive Findings in Carcinogenicity Studies -- Investigating Tumor Signals in Clinical Trials -- Tumor Promoters -- Carcinogenicity Testing of Biologics -- In Silico Predictive Tests. | |
| 520 | _aThis book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs. | ||
| 650 | 0 | _aMedicine. | |
| 650 | 0 | _aCancer research. | |
| 650 | 0 | _aPharmaceutical technology. | |
| 650 | 1 | 4 | _aBiomedicine. |
| 650 | 2 | 4 | _aCancer Research. |
| 650 | 2 | 4 | _aPharmaceutical Sciences/Technology. |
| 700 | 1 |
_aGraziano, Michael J. _eeditor. |
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| 700 | 1 |
_aJacobson-Kram, David. _eeditor. |
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| 710 | 2 | _aSpringerLink (Online service) | |
| 773 | 0 | _tSpringer eBooks | |
| 776 | 0 | 8 |
_iPrinted edition: _z9783319220833 |
| 856 | 4 | 0 | _uhttp://dx.doi.org/10.1007/978-3-319-22084-0 |
| 912 | _aZDB-2-SBL | ||
| 999 |
_c4129 _d4129 |
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