000			03982cam a2200589Mi 4500
001			ocn872703723
003			OCoLC
005			20210921181052.0
006			m o d
007			cr |n|||||||||
008			140224s2014 flua |ob 001|0 eng d
020			_a9781841849201 _q(electronic bk.)
020			_a9781841849201
020			_a1841849200 _q(electronic bk.)
020			_z9781841849195 _q(hardcover ; _qalk. paper)
020			_z1841849197 _q(hardcover ; _qalk. paper)
029	1		_aNZ1 _b15585832
029	1		_aGBVCP _b777722348
035			_a(OCoLC)872703723 _z(OCoLC)869639807 _z(OCoLC)960113896 _z(OCoLC)985182367
040			_aCNSPO _beng _epn _cCNSPO _dOCLCO _dOCLCF _dOCLCO _dAZU _dYDXCP _dOCLCA _dUIU _dCRCPR _dOCLCQ _dEBLCP _dE7B _dOCLCQ _dCAUOI _dOCLCQ _dOCLCO _dOCLCA _dYDX _dOCLCO _dOCLCQ _dOCLCA _dMERUC _dOCLCO _dOCLCA
043			_an-us---
245	1	0	_aFDA regulatory affairs : _b[electronic book] /
250			_a3rd edition.
264		1	_aBoca Raton, Florida : _bCRC Press, _c2014.
300			_a1 online resource (xii, 387 pages).
336			_atext _btxt _2rdacontent
336			_atext _2rdacontent
337			_acomputer _bc _2rdamedia
337			_acomputer _2rdamedia
338			_aonline resource _bcr _2rdacarrier
338			_aonline resource _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aOverview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory -- Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the gxps for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner.
520	8		_aThis third edition of 'FDA Regulatory Affairs' examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. Focusing on new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements this is a key title for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, this book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
610	1	0	_aUnited States. _bFood and Drug Administration _vRules and practice.
610	1	2	_aUnited States _bFood and Drug Administration.
650		0	_aDrug development.
650		0	_aDrug development _zUnited States.
650		0	_aPharmaceutical industry _zUnited States.
650	1	2	_aUnited States Government Agencies.
650	2	2	_aBiological Factors _xstandards.
650	2	2	_aEquipment and Supplies _xstandards.
650	2	2	_aGovernment Regulation.
651		2	_aUnited States.
700	1		_aMantus, David, _eeditor.
700	1		_aPisano, Douglas J., _eeditor.
710			_aEBSCO _evendor
856	4	0	_uhttp://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,sso&db=nlebk&AN=686544&site=ehost-live&custid=s7813921 _zAccess ebook here
942			_2ddc _cSG_8 _n0
948			_hNO HOLDINGS IN LQI - 61 OTHER HOLDINGS
998			_en
999			_c266991 _d266991