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006			m o d
007			cr cnu|||unuuu
008			170427s2017 sz o 001 0 eng d
020			_a3319548026 _q(electronic bk.)
020			_a9783319548029 _q(electronic bk.)
020			_z331954800X
020			_z9783319548005 _q(print)
040			_aN$T _cN$T _dGW5XE _dYDX _dN$T _dUAB _dOCLCO _dESU _dAZU _dUPM _dIOG _dOCLCO _dOCLCF _dCOO _dOTZ _dVT2 _dOCLCQ _dOCLCO _dJG0 _dOCLCO _dU3W _dOCLCO _dOCLCA _dES-MaUEC _bspa
050		4	_aRS189 _b.R448 2017 EB
245	0	0	_aRegulated bioanalysis : _bfundamentals and practice _cMario L. Rocci Jr., Stephen Lowes, editors.
264		1	_aCham, Switzerland _bSpringer _c2017.
300			_a1 recurso en línea
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
347			_atext file _bPDF _2rda
490	0		_aAAPS advances in the pharmaceutical sciences series _x2210-7371 _vvolume 26
500			_aIncluye índice
500			_aSpringerLink
505	0		_aIntroduction -- Understanding Bioanalysis Regulations -- Logistical and Operational Practice in the Regulated Bioanalysis Laboratory -- Regulated Bioanalysis: Documentation and Reports -- Historical Aspects and Key Concepts Related to its Use -- Fundamentals of LC-MS/MS for Regulated Bioanalysis -- Liquid Chromatography-Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory -- Development and maintenance of critical reagents for ligand binding assays to support regulatory-compliant bioanalysis -- Ligand Binding Assays in the Regulated Bioanalytical Laboratory.
520	3		_aThis book is intended to cover the fundamental and practical aspects of regulated bioanalysis. The editors are seeking leading scientists in the field to participate in the development of this book, which we envision as a "one of a kind" contribution to our field. The book is intended for students in the pharmaceutical sciences, chemistry, biology and related scientific disciplines interested in bioanalysis, as well as working scientists new to the field of regulated bioanalysis. It will also serve as a primer for those experienced in the field. The depth of the book will seek to give its audience a solid foundation of knowledge in regulated bioanalysis which can be leveraged further with "hands on" experience. Understanding that bioanalytical global regulations evolve, the book is not intended as a deep-dive into regulatory language nuances but rather to be an educational text on conducting defendable and auditable science to support modern bioanalysis. Following an introduction to the topic by the editors, the book then covers "non-scientific" aspects of the topic area including the regulations governing this work, logistical and operational aspects of running a regulated bioanalytical laboratory and appropriate laboratory documentation. Next a description of the typically encountered types of bioanalytical samples, analytes and their attributes is provided. This information then sets the stage for a detailed discussion of the analytical platforms and assay types used in the regulated bioanalysis of small and large molecules. Also provided is a discussion of the different analytical phases of the bioanalytical process (i.e. method development including various strategies, pre-study validation and sample analysis).
988			_aEBOOK, asignarmaterias, EBSPRINGER_2017C
650		7	_aDrogas _xAnálisis _2embne _0(OCoLC)fst00898769 _9139235
700	1		_aLowes, Stephen, _eeditor literario
700	1		_aRocci, Mario L., _eeditor literario
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=http://link.springer.com/10.1007/978-3-319-54802-9 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b02/2018 _dz _e- _zSI