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999			_c81384 _d81384 _x1
001			81384
003			ES-MaUEC
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007			cr nn 008mamaa
008			150624s2015 gw | s |||| 0|eng d
020			_a9783319162416
040			_aES-MaUEC
050		4	_aRS380 _b.N663 2015 EB
245	0	0	_aNon-Biological Complex Drugs : _bThe Science and the Regulatory Landscape _cedited by Daan J.A. Crommelin, Jon S. B. de Vlieger
260			_aCham, Switzerland _bSpringer _c2015
300			_a1 recurso en línea (IX, 390 p.) 91 il., 57 il. col.
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	1		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v20
520			_aThe rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs.Â{u036F}reover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.Â{uE000}
650		7	_aBiotecnología farmacéutica _9155839 _0comprobar BNE19996549239 _2embne
700			_aCrommelin, Daan J. A. _eeditor literario _984705 _0Local
700	1		_aVlieger, Jon S. B. de _eeditor literario _993770 _0Local
830		0	_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v20 _9133175
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-16241-6 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9783319162416
907			_a.b12899744 _b10-10-17 _c18-01-16
942			_2lcc _cLE
945			_aRS380 .N663 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11569360 _z06-04-17
988			_aEBOOK, EBSPRINGER
998			_am _a_alco _a_vill _b13-03-17 _cm _dz _ek _feng _ggw _h0