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001			75949
003			ES-MaUEC
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008			130410s2013 xxu| s |||| 0|eng d
020			_a9781461462965
040			_aES-MaUEC
050		4	_aRS403 _b.G66 2013 EB
245	0	0	_aGood Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products _cedited by Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina
260			_aBoston, MA _bSpringer International Publishing _c2013
300			_a1 recurso en línea (XII, 442 p.) 254 il., 216 il. col.
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
520			_aAerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.Â{u0525}sting based on cascade impaction has been the primary tool used to characterize this critical quality attribute and is a regulatory expectation for Quality Control purposes.Â{u026E} recent years, there have been substantial efforts directed at improving aerodynamic particle size determinations. Â{u01EF}od Cascade Impactor Practices, AIM and EDA forÂ{uFCA1}ally Inhaled Products brings together for the first time a review of best practices for performing cascade impactor testing with a thorough discussion of theÂ{u2963}ently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA). Â� Topics covered include: ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) ofÂ{uF250}Ps. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Introduction of the AIM and EDA concepts. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Selection of the type of testing through the development lifecycle of an OIP. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Theoretical basis for EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Performance evaluation of EDA as a quality control element. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Case studies related to the application ofÂńA.·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Experimental studies validating the AIM concept conducted by European Pharmaceutical Aerosol Group (EPAG) and the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Regulatory and compendial pathways to adoption of AIM and EDA. ·Â{u2802}Â{u2802}Â{u2802}Â{u2820} Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract.Â� This comprehensive volume was written by a group of prominent international experts in aerosol testing led by members of the Cascade Impaction Working Group of IPAC-RS.Â{u0250}AC-RS is an international association of pharmaceutical companies committed to advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products
942			_2lcc _cLE
988			_aEBOOK, EBSPRINGERrevisado
650		7	_aQuímica farmacéutica _0comprobar BNE19901004645 _2embne _9141808
700	1		_aTougas, Terrence P. _eeditor _984692 _0Local
700	1		_aMitchell, Jolyon P _eeditor literario _984693 _0Local
700	1		_aLyapustina, Svetlana A _eeditor literario _984694 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4614-6296-5 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9781461462965
907			_a.b12815676 _b10-10-17 _c01-10-14
998			_am _a_alco _a_vill _b13-03-17 _cm _dz _ek _feng _gxxu _h0
945			_aRS403 .G66 2013 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11545057 _z06-04-17
999			_c75949 _d75949 _x1