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001			289333
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008			150903s2005 xxu| o |||| 0|eng d
020			_a9781592598847 _99781592598847
024	7		_a10.1007/9781592598847 _2doi
035			_avtls000342835
039		9	_a201509030858 _bVLOAD _c201405050248 _dVLOAD _y201402061136 _zstaff
040			_aMX-SnUAN _bspa _cMX-SnUAN _erda
050		4	_aRM1-950
100	1		_aMorganroth, Joel. _eeditor. _9319512
245	1	0	_aCardiac Safety of Noncardiac Drugs : _bPractical Guidelines for Clinical Research and Drug Development / _cedited by Joel Morganroth, Ihor Gussak.
264		1	_aTotowa, NJ : _bHumana Press, _c2005.
300			_brecurso en línea.
336			_atexto _btxt _2rdacontent
337			_acomputadora _bc _2rdamedia
338			_arecurso en línea _bcr _2rdacarrier
347			_aarchivo de texto _bPDF _2rda
500			_aSpringer eBooks
505	0		_aCardiac Safety of Noncardiac Drugs -- Preclinical and Pharmacogenomic Cardiac Safety Evaluations -- Molecular Physiology of Ion Channels That Control Cardiac Repolarization -- Cellular, Molecular, and Pharmacologic Mechanisms Underlying Drug-Induced Cardiac Arrhythmogenesis -- hERG Assay, QT Liability, and Sudden Cardiac Death -- Pharmacogenomics in Drug Development -- Clinical Methodologies and Technical Aspects of Assessing Cardiac Safety of Investigational Drugs: Focus on Cardiac Repolarization -- Assessment of Ventricular Repolarization From Body-Surface ECGs in Humans -- ECG Acquisition and Signal Processing -- Digital 12-Lead Holter vs Standard Resting Supine Electrocardiogram for the Assessment of Drug-Induced QTc Prolongation -- Holter Monitoring for QT -- Application of ELectrocardiology in Clinical Research -- Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment -- Design and Conduct of the Thorough Phase I ECG Trial for New Bioactive Drugs -- Use of ECGs in Support of Cardiac Safety in Phase II and III Clinical Trials -- Cardiac Arrhythmia Assessment in Phase IV Clinical Studies -- Statistical Analysis Plans for ECG Data -- Interpretation of Clinical ECG Data -- Regulatory COnsiderations -- The FDA’s Digital ECG Initiative and Its Impact on Clinical Trials -- Quality Control and Quality Assurance for Core ECG Laboratories -- ECG Digital Communities and Electronic Reporting of Cardiac Safety Data.
520			_aAlthough it is relatively easy to determine the efficacy of a new drug, it is difficult to establish its safety when administered to millions of patients with multifaceted diseases, co-morbidities, sensitivities, and multiple drug use. In Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development, basic and clinical researchers from industry and academia detail the preclinical, clinical, and regulatory principles currently used to assess the cardiac safety of new drugs from their effects on the electrocardiogram (ECG). The authors explain the parameters of cardiac safety at all stages of clinical research and drug development, including both the preclinical and pharmacogenomic aspects generally and the clinical methodologies and technical aspects for investigational drugs based on cardiac repolarization, as defined by the duration of the QTc interval. Additional chapters comprehensively review the application of electrocardiology in clinical research, demonstrating the fundamentals of ECG interpretation in clinical trials, the statistical analysis plans for ECG data obtained in formal clinical trials, and the practical interpretation of the results. Highlights include practical guidance on how to conduct a thorough ECG Trial in New Drug Development, how to use new ECG and web-based technology in clinical research, and how to follow the new FDA requirements for ECG submissions. Authoritative and up-to-date, Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development offers clinical researchers in industry and academia expert practical advice on establishing their product's cardiac safety, predicting regulatory actions, and getting it successfully to market.
590			_aPara consulta fuera de la UANL se requiere clave de acceso remoto.
700	1		_aGussak, Ihor. _eeditor. _9315248
710	2		_aSpringerLink (Servicio en línea) _9299170
776	0	8	_iEdición impresa: _z9781588295156
856	4	0	_uhttp://remoto.dgb.uanl.mx/login?url=http://dx.doi.org/10.1007/978-1-59259-884-7 _zConectar a Springer E-Books (Para consulta externa se requiere previa autentificación en Biblioteca Digital UANL)
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