000			03787nam a22004575i 4500
001			60030
005			20200226102305.0
007			cr nn 008mamaa
008			160728s2017 gw | s |||| 0|eng d
020			_a9783319403472 _9978-3-319-40347-2
024	7		_a10.1007/978-3-319-40347-2 _2doi
035			_a(DE-He213)978-3-319-40347-2
050		4	_aRS1-441
072		7	_aMMG _2bicssc
072		7	_aMED071000 _2bisacsh
082	0	4	_a353.998 _223
100	1		_aTurner, J. Rick. _eauthor.
245	1	0	_aCardiovascular Safety in Drug Development and Therapeutic Use _h[electronic resource] : _bNew Methodologies and Evolving Regulatory Landscapes / _cby J. Rick Turner, Dilip R. Karnad, Snehal Kothari.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Adis, _c2017.
300			_aXXVI, 333 p. 2 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
505	0		_aThe Central Importance of Cardiovascular Safety in Contemporary New Drug Development -- The Biological Basis of Drug Responses -- Cardiovascular Structure, Function, Pathophysiology, & Disease -- The Current Regulatory Landscape -- The "Comprehensive In Vitro Proarrhythmia Assay" Initiative -- The "Early ECG Assessment" Initiative -- The "Submission of Extended Digital ECG Data" Initiative -- Meta-analysis and Meta-methodology -- Current Regulatory Landscapes and their Potential Evolution -- Off-target Blood Pressure Responses to Non-cardiovascular Drugs -- Oncology Drug Development and Therapeutics: Cardiotoxicity Considerations -- Postmarketing Surveillance -- Regulatory Perspectives on General Drug Safety -- Future Directions in Cardiovascular Safety -- References.
520			_aWith the advent of multiple new therapeutic agents for a variety of important diseases has come an increasing realization that many of these drugs can have adverse effects on the heart and vascular system. As this book so elegantly details the mechanisms by which harm occurs are highly complex, many times predictable, but always clinically relevant. Notable experts in the field of cardiovascular medicine, such as Drs. Turner, Karnad, and Kothari, have turned their attention to this thorny problem, and begun to dissect the diverse mechanisms by which cardiac harm can occur with a variety of non-cardiac drugs. This is no easy task, given the complexity of the diseases we treat, and the wide spectrum of new therapies we seek to apply. However, it is an issue with which all health care providers must become familiar in order to prescribe appropriate therapy while safeguarding patients against avoidable and life-threatening cardiac adverse effects. This compendium represents the state-of-the-art in the evolving field of cardiac safety and is vital reading for those interested in developing new chemical entities, as well as those who prescribe them and monitor patients for their hazard. As such, I recommend this book as essential reading for students, scientists, and health care providers at all levels of training. Peter R. Kowey, MD, FACC, FAHA, FHRS Lankenau Institute for Medical Research & Thomas Jefferson University.
650		0	_aMedicine.
650		0	_aCardiology.
650		0	_aPharmacy.
650	1	4	_aMedicine & Public Health.
650	2	4	_aDrug Safety and Pharmacovigilance.
650	2	4	_aCardiology.
700	1		_aKarnad, Dilip R. _eauthor.
700	1		_aKothari, Snehal. _eauthor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783319403458
856	4	0	_uhttp://dx.doi.org/10.1007/978-3-319-40347-2
912			_aZDB-2-SME
999			_c1198 _d1198