000			03749cam a2200445 i 4500
003			BUC
005			20220222073756.0
008			140709t20142014nyua b 001 0 eng c
010			_a2014945359
020			_a9781493912513 (alk. paper)
020			_a1493912518 (alk. paper)
040			_aBADR UNIVERSITY IN CAIRO _beng _cBADR UNIVERSITY IN CAIRO _erda
043			_an-us---
050	0	0	_aRM301.45 _b.F33 2014
082			_223 _a615.19 _bFDB
245	0	0	_aFDA bioequivalence standards / _cLawrence X. Yu, Bing V. Li, editors.
260			_aNew York : _bAAPS Press/Springer, _c2014.
300			_axiii, 465 p. : _billustrations ; _c24 cm
336			_a36
490	1		_aAAPS advances in the pharmaceutical sciences series, _v13
504			_aIncludes bibliographical references and index.
505			_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			_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.--
610	1	0	_aUnited States. _bFood and Drug Administration.
610	1	2	_aUnited States. _bFood and Drug Administration.
650		0	_aDrugs _xTherapeutic equivalency _xStandards _zUnited States.
650		0	_aDrugs _xResearch _xStandards _zUnited States.
650	1	2	_aDrugs, Generic _xstandards.
650	1	2	_aTherapeutic Equivalency.
650	2	2	_aGovernment Agencies _xstandards.
700	1		_aYu, L. X. _eeditor.
700	1		_aLi, Bing V., _eeditor.
830		0	_aAAPS advances in the pharmaceutical sciences series ; _vv. 13.
902			_aM.Said
942			_2ddc _cBK
999			_c292 _d292