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008			151102s2015 gw | s |||| 0|eng d
020			_a9783319220840
024	7		_a10.1007/978-3-319-22084-0 _2doi
050		4	_aRC268.65 _bG466 2015
245	1	0	_aGenotoxicity and Carcinogenicity Testing of Pharmaceuticals _cedited by Michael J. Graziano, David Jacobson-Kram.
250			_a1st ed. 2015.
260			_aCham, Switzerland _bSpringer _c2015
300			_a1 recurso en línea (X, 206 páginas) _b15 ilustraciones, 8 ilustraciones en color
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
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	3		_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. Â{u01E5}notoxicity 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.
710	2		_aSpringerLink (Online service) _0Local _9106996
942			_2lcc _cLE
988			_aEBOOK, asignarmaterias, EBSPRINGER,
650		7	_aTecnología farmacéutica _2embne _9161127
650	2	7	_aFarmacia _2embne _9137891
700	1		_aGraziano, Michael J. _eeditor literario _0Local _993959
700	1		_aJacobson-Kram, David _eeditor literario _993960 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-22084-0 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12900898 _b10-10-17 _c18-01-16
998			_am _a_alco _a_vill _b - - _cm _dz _e- _feng _ggw _h0
945			_aRC268.65 G466 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11570519 _z06-04-17
999			_c81499 _d81499 _x1