000			03333nam a2200409 a 4500
001			0000134149
005			20171002061243.0
006			m u
007			cr cn|||||||||
008			100113s2010 njua sb 001 0 eng d
010			_z 2009054243
020			_z9780470121948 (hbk.)
020			_z9780470630709 (e-book)
035			_a(CaPaEBR)ebr10469614
035			_a(OCoLC)732958459
040			_aCaPaEBR _cCaPaEBR
050	1	4	_aRS189 _b.P66 2010eb
082	0	4	_a615/.1901 _222
245	0	0	_aPractical approaches to method validation and essential instrument performance verification _h[electronic resource] / _cedited by Chung C. Chan, Herman Lam, Xue-Ming Zhang.
260			_aHoboken, N.J. : _bWiley, _cc2010.
300			_axiv, 399 p. : _bill.
500			_aComplement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.
504			_aIncludes bibliographical references and index.
505	8		_a(Publisher-supplied data ) Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems (LIMS) / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction.
520			_a"The objective of this book is provide information in same practical, hands-on manner as the first book "Analytical Method Validation and Instrument Performance Verification", on important, but more advance topics. It will focus on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testings. These tests will generate reliable data that is in compliance with current Good Manufacturing Practices (cGMP) and will follow Good Analytical Practices"--Provided by publisher.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2011. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
650		0	_aDrugs _xAnalysis _xMethodology _xEvaluation.
650		0	_aLaboratories _xEquipment and supplies _xEvaluation.
650		0	_aLaboratories _xInstruments _xEvaluation.
655		7	_aElectronic books. _2local
700	1		_aChan, Chung Chow.
700	1		_aLam, Herman.
700	1		_aZhang, Xue-Ming.
710	2		_aebrary, Inc.
856	4	0	_uhttp://site.ebrary.com/lib/daystar/Doc?id=10469614 _zAn electronic book accessible through the World Wide Web; click to view
908			_a170314
942	0	0	_cEB
999			_c123298 _d123298