000			03057nam\a2200385\a\4500
001			57998
005			20260819122702.0
008			260819s2014 flua b 001 0 eng
020			_a9781420086355 _qhbk. : alk. paper
020			_a9781420086362 _qeBook
035			_a(DNLM)101606012
040			_aDNLM/DLC _cDLC _dBD-DhIUB
082	0	0	_a615.19 _223 _bG3261
245	0	0	_aGeneric drug product development : _bsolid oral dosage forms / _cedited by Leon Shargel, Isadore Kanfer.
250			_a2nd ed.
260			_aBoca Raton, FL : _bCRC Press/Taylor & Francis Group, _cc2014. (reprint 2024)
300			_axii, 385 p. : _bill. ; _c25 cm.
490	0		_aDrugs and the pharmaceutical sciences ; _v129
504			_aIncludes bibliographical references and index.
505	0		_aActive pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.
520			_a"This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.
526			_aPHR _bphr _lPHAR
541			_aOmni concept
650		0	_aGeneric drugs.
650		0	_aSolid dosage forms.
650	1	2	_aDrugs, Generic _xstandards.
650	2	2	_aChemistry, Pharmaceutical _xstandards.
650	2	2	_aDrug Approval.
650	2	2	_aTablets.
700	1		_aShargel, Leon, _d1941-
700	1		_aKanfer, Isadore.
942			_2ddc _cBK
999			_c57998 _d58172