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008			150421s2015 gw | s |||| 0|eng d
020			_a9783319158051
024	7		_a10.1007/978-3-319-15805-1 _2doi
050		4	_aRM301.27 _b2015 EB
100	1		_aLeong, James _0Local _995190
245	1	0	_aBenefit-Risk Assessment of Medicines : _bThe Development and Application of a Universal Framework for Decision-Making and Effective Communication _cby James Leong, Sam Salek, Stuart Walker.
260			_aCham _bSpringer International Publishing _bImprint: Adis _c2015.
300			_a1 recurso en línea (XIII, 317 páginas) _b163 ilustraciones, 138 ilustraciones en color
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_aPrologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References.
520	3		_aThis book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed, and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.
710	2		_aSpringerLink (Online service) _0Local _9106996
942			_2lcc _cLE
650		7	_aMedicina _xInvestigación _0 _2embne _9168783
650		7	_aFarmacia _0 _2embne _9137891
650		7	_aCalidad de vida _0 _2embne _9153202
700	1		_aSalek, Sam. _936810 _0comprobar BNE20041056877
700	1		_aWalker, Stuart. _995191 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-15805-1 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12909701 _b10-10-17 _c10-02-16
988			_aSpringer_Medicine_2015
998			_am _a_alco _a_vill _b - - _cm _dz _e- _feng _ggw _h0
945			_aRM301.27 L466 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11577381 _z06-04-17
999			_c82330 _d82330 _x1