000			03404nam a22003615a 4500
001			11007392
005			20160217143648.0
008			141103t2014 nyua frb 001 0 eng d
020			_a9781493912513
040			_aEG-ScBUE _beng _cEG-ScBUE _dEG-ScBUE
082	0	4	_a615.1 _222 _bFDA
245	1	0	_aFDA Bioequivalence Standards / _cedited by Lawrence X. Yu, Bing V. Li.
260			_aNew York : _bAAPS Press : _bSpringer, _cc.2014.
300			_axiii, 465 p. : _bill. ; _c24 cm.
490	0		_aAAPS Advances in the Pharmaceutical Sciences Series, _x2210-7371 ; _v13
500			_aIndex : p. 463-465.
504			_aIncludes bibliographical references.
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.
506			_aLicense restrictions may limit access.
520			_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.
650		7	_aDrugs _2BUEsh _xTherapeutic equivalency. _939375
650		0	_aDrugs _xStandards _2BUEsh _zUnited States
651			_2BUEsh
653			_bPPhrm _cFebruary2016
700	1		_aYu, Lawrence X., _eeditor.
700	1		_aLi, Bing V., _eeditor.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
773		0	_tSpringerLINK ebooks - Biomedical and Life Sciences (2014)
776	0	8	_iPrinted edition: _z9781493912513
910			_aVendor-generated brief record
942			_2ddc
999			_c21179 _d21151