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007			cr nn 008mamaa
008			140905s2014 xxu| s |||| 0|eng d
020			_a9781493912520
024	7		_a10.1007/978-1-4939-1252-0 _2doi
050		4	_aRM301.45 _bY853 2014
100	1		_aYu, Lawrence X. _eeditor literario _985068 _0Local
245	1	0	_aFDA Bioequivalence Standards _cedited by Lawrence X. Yu, Bing V. Li.
260			_aNew York _bSpringer International Publishing _c2014
300			_a1 recurso en línea (XIII, 465 páginas) _b58 ilustraciones, 26 ilustraciones en color
336			_aTexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series _x2210-7371 _v13
505	0		_a1 Bioequivalence History -- 2 Fundamentals of Bioequivalence -- 3 Basic Statistical Considerations -- 4 The Effects of Food on Drug Bioavailability and Bioequivalence -- 5 Bio waiver and Biopharmaceutics Classification System -- 6 Bioequivalence of Highly Variable Drugs -- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments -- 8 Bioequivalence for Narrow Therapeutic Index Drugs -- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies -- 10 Clinical Endpoint Bioequivalence Study -- 11 Bioequivalence for Liposomal Drug Products -- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract -- 13 Bioequivalence for Topical Drug Products -- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products -- 15 Bioequivalence: Modeling and Simulation -- 16 Bioanalysis.
520	3		_aThis comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
942			_2lcc _cLE
988			_aEBOOK, EBSPRINGERrevisando, asignarmaterias_11febrero
650		7	_aTecnología farmacéutica _0 _2embne _9161127
650	2	7	_aFarmacia _0 _2embne _9137891
700	1		_aLi, Bing V. _eeditor literario _0Local _985069
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4939-1252-0 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12817776 _b10-10-17 _c01-10-14
998			_am _a_alco _a_vill _b - - _cm _dz _e- _feng _gxxu _h0
945			_aRM301.45 Y853 2014 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11546992 _z06-04-17
999			_c76159 _d76159 _x1