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007			cr cnu---unuuu
008			120913s2008 nyua sb 001 0 eng d
020			_a9781420070439 (ebk.)
020			_a1420070436 (ebk.)
020			_a9786611948726
020			_a6611948724
020			_z1420070428 (Cloth)
020			_z9781420070422
035			_a(OCoLC)312146716
035			_a(OCoLC)ocn312146716
039		9	_a201209131004 _bshuhada _y201209131002 _zshuhada
043			_an-us---
082	0	4	_a344.7304/233 _222
245	0	4	_aThe pharmaceutical regulatory process _h[electronic resource] / _cedited by Ira R. Berry, Robert P. Martin.
250			_a2nd ed.
260			_aNew York : _bInforma Healthcare, _cc2008.
300			_a1 online resource (x, 469 p.) : _bill.
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.
505	0		_aClinical 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 -- Active 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.
505	0		_aCurrent 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.
588			_aDescription based on print version record.
650		0	_aPharmacy _xLaw and legislation _zUnited States. _921087
650		0	_aDrugs _xLaw and legislation _zUnited States. _921088
650		0	_aElectronic books.
700	1		_aBerry, Ira R., _d1942- _921089
700	1		_aMartin, Robert P. _q(Robert Paul) _964571
776	0	8	_iPrint version: _tPharmaceutical regulatory process. _b2nd ed. _dNew York : Informa Healthcare, c2008 _z9781420070422 _z1420070428 _w(DLC) 2008042661 _w(OCoLC)259902129
830		0	_aDrugs and the pharmaceutical sciences ; _vv. 185. _921072
856	4	0	_uhttps://ezproxy.taylors.edu.my/login?url=http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=260345 _zAn electronic book accessible through the World Wide Web; click to view
999			_c145243 _d145243