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001			75933
003			ES-MaUEC
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007			cr nn 008mamaa
008			130217s2013 xxu| s |||| 0|eng d
020			_a9781461459507
040			_aES-MaUEC
050		4	_aRM301.27 _bG56 2013 EB
245	0	0	_aGlobal Approach in Safety Testing : _bICH Guidelines Explained _cedited by Jan Willem van der Laan, Joseph J. DeGeorge
260			_aNew York _bSpringer International Publishing _c2013
300			_a1 recurso en línea (XII, 315 p.) 15 il., 13 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 _v5
520			_aThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA). In Europe, the members are the EU (Representatives of the European Commission and the European Medicines Agency [EMA]), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the United States, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA)Â{u0A73} the secretariat of the ICH. Additional members include Observers from WHO, European Free Trade Association (EFTA), and Canada. The Observers represent non-ICH countries and regions. This volume considers one ofÂ{u0243}Hâ€{u382D}ajor categories, Safety,Â{u08EF}vering topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, butÂ{u0A6E} most casesÂ{u0D28}ere is a lack of awareness of the many issues that were addressed during the development of the consensus guidances.Â{u6D72}rther, just as it is important to understand what the guidances state, it is also important to understand the thoughts, debates, and intent of the experts involved, which are not included in the guidance documents. Why has the guideline been written as it is written,Â{u0DE8}y are some topics ignored, and Â{u7A39} have some initial guidance proposals haveÂ{u08A5}en deleted. These and other related questions and answers are the contents of this book, written by experts who were directly involved in writing the ICH guidances that drive drug development today
942			_2lcc _cLE
988			_aEBOOK, EBSPRINGERrevisado
650		7	_aMedicamentos _xEnsayos clínicos _0comprobar BNE20022316776 _2embne _9331970
700	1		_aDeGeorge, Joseph J. _eeditor literario _0Local _984663
700	1		_avan der Laan, Jan Willem _eeditor _984664 _0Local
830		0	_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v5 _9133175 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4614-5950-7 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9781461459507
907			_a.b12815512 _b10-10-17 _c01-10-14
998			_am _a_alco _a_vill _b13-03-17 _cm _dz _ek _feng _gxxu _h0
945			_aRM301.27 G56 2013 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11544892 _z06-04-17
999			_c75933 _d75933 _x1