000			03656cam a22005054a 4500
005			20250918235653.0
008			140716s2014 flua b 001 0 eng
020			_a9781420086355 (hbk. : alk. paper) _cRM684.38
020			_a1420086359 (hbk. : alk. paper)
020			_a9781420086362 (eBook)
020			_a1420086367 (eBook)
039		9	_a201504280933 _bzainol _y07-16-2014 _zfida
040			_aDNLM/DLC _beng _cDLC _dBTCTA _dBAKER _dYDXCP _dNLM _dOCLCO _dTMY _dIG# _dOCLCF _dCDX _dIXA _dOCLCO
040			_aUKM _erda
090			_aQV771.G326 2014 9
090			_aQV771 _b.G326 2014 9
245	0	0	_aGeneric drug product development : _bsolid oral dosage forms / _cedited by Leon Shargel, Isadore Kanfer.
250			_aSecond edition.
260			_aBoca Raton, FL : _bCRC Press/Taylor & Francis Group, _c2014.
300			_axii, 385 p. : _billustration ; _c25 cm.
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
490	1		_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.
650		2	_aDrugs, Generic _xstandards.
650		2	_aChemistry, Pharmaceutical _xstandards.
650		2	_aDrug Approval.
650		2	_aTablets.
650		7	_aGeneric drugs. _2fast _0(OCoLC)fst00939969
650		7	_aSolid dosage forms. _2fast _0(OCoLC)fst01125411
700	1		_aShargel, Leon, _d1941-
700	1		_aKanfer, Isadore.
830		0	_aDrugs and the pharmaceutical sciences ; _vv. 129.
907			_a.b15952034 _b2019-11-12 _c2019-11-12
942			_c01 _n0 _kQV771.G326 2014 9
914			_avtls003565101
990			_azr
991			_aFakulti Farmasi, KKL
998			_ad _b2014-03-07 _cm _da _feng _gflu _y0 _z.b15952034
999			_c574583 _d574583