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008			221130s2022 sz | s |||| 0|eng d
020			_a9783031044021
024	7		_a10.1007/978-3-031-04402-1 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aRA645 .C3 _b2022 EB
245	0	0	_aCancer Drug Safety and Public Health Policy : _bA Changing Landscape _cedited by Charles Bennett, Courtney Lubaczewski, Bartlett Witherspoon
250			_a1st edition 2022
264		1	_aCham _bSpringer International Publishing _c2022
300			_a1 recurso en línea (XI, 167 páginas) _b16 ilustraciones, 10 ilustraciones a color
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
347			_aarchivo de texto _bPDF
490	0		_aCancer Treatment and Research _x2509-8497 _v184
505	0		_aFluoroquinolone-Associated Disability and Other Fluoroquinolone Associated Serious Adverse Events: Unexpected Toxicities Have Emerged in Recent Years -- Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions -- Policing of Drug Safety Information under the False Claims Act -- Translating Research Into Health Policy: The Citizen Petition Experience with the Food and Drug Administration -- Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions -- Was there Something Rotten in Denmark: Nephrogenic System Fibrosis Cases Occuring in Copenhagen -- Rituximab-associated Progressive Multifocal Leukoencephalopathy: A fatal adverse drug reaction -- Maximum Accuracy Machine Learning Statistical Analysis - A Novel Approach -- Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work -- Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR) -- Moderna, Pfizer-BioNTech, and Johnson & Johnson/Janssen Post-Covid Vaccine Hematological Adverse Events Including Cerebral Venous Sinus Thrombosis (CVST), Thrombotic Thrombocytopenia (VITT), Blood Clots, Increased Vaginal/Menstrual Bleeding and/or Miscarriage, Stillbirth Delivery, or Premature Birth -- Investigating Novel Genetic Fluoroquinolone Associated Disorders.
520			_aThis book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention - these fines are playing an important role in changing the landscape for pharmaceutical safety.
988			_aSpringer_Medicine_2022
650		7	_2embne _9139308 _aCáncer _xPolítica gubernamental
700	1		_aBennett, Charles _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aLubaczewski, Courtney _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aWitherspoon, Bartlett _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9783031044014
776	0	8	_iPrinted edition: _z9783031044038
776	0	8	_iPrinted edition: _z9783031044045
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-031-04402-1 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b01/2023 _dz _eu _zSI