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999			_c11917 _d11917
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003			EG-NcFUE
005			20200216144714.0
008			080926s2018 nyua 001 0 eng
010			_a 2008042661
016	7		_a101485457 _2DNLM
020			_a9781138381285
020			_a9781420070422
020			_z9781420070422 (hardcover : alk. paper)
020			_z1420070428 (hardcover : alk. paper)
035			_a(OCoLC)ocn259902129
035			_a(OCoLC)259902129 _z(OCoLC)166379234
040			_aDNLM/DLC _cDLC _dBTCTA _dBAKER _dYDXCP _dNLM _dC#P _dBWX _dDLC
043			_an-us---
082	0	0	_a344.7304233 _222 _bP.
245	0	4	_aThe pharmaceutical regulatory process / _cedited by Ira R. Berry, Robert P. Martin.
250			_aSecond edition.
264		1	_aBoca Raton : _bCRC Press, _c2018.
300			_ax, 469 pages : _billustrations; _c24 cm.
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
490	1		_aDrugs and the pharmaceutical sciences ; _v185
504			_aIncludes bibliographical references and index.
505	0		_aPharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug approval- process - before and after 1962 / Michael P. Peskoe -- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England.
505	0		_aActive pharmaceutical ingredients / Max S. Lazar -- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham.
650		0	_aPharmacy _xLaw and legislation _zUnited States.
650		0	_aDrugs _xLaw and legislation _zUnited States.
650	1	2	_aLegislation, Drug _zUnited States.
650	2	2	_aGuideline Adherence _xlegislation & jurisprudence _zUnited States.
650	2	2	_aPharmaceutical Preparations _xstandards _zUnited States.
700	1		_aBerry, Ira R., _d1942-
700	1		_aMartin, Robert P. _q(Robert Paul)
830		0	_aDrugs and the pharmaceutical sciences ; _vv. 185.
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK