000			01804cam a2200373 i 4500
999			_c12882 _d12882
001			55589671
005			20210307111803.0
008			040604s2004 nyua b 001 0 eng
020			_a0824750411
040			_aYEH _cYEH _dIXA _dMXC _erda
082	0	4	_222 _a615.1 _bN.
245	0	0	_aNew drug approval process : _baccelerating global registrations / _cedited by Richard A. Guarino, M.D., oxford pharmaceutical resources, inc., Totowa, New Jersey, U.S.A.
250			_aFourth edition
264		1	_aNew York : _bMarcel Dekker Inc., _c[2004]
264		4	_c©2004
300			_axiv, 635 pages : _billustrations (black and white) ; _c24 cm
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
490	1		_aDrugs and the pharmaceutical sciences ; _vv. 139
504			_aIncludes bibliographical references and index
505	0		_a pt. 1. Regulatory practices and procedures of new drug, biologic, and device development -- pt. 2. Clinical research development -- pt. 3. Specific aspects in the process of new product submissions -- pt. 4. Global applications of good clinical practices (GCPs) -- pt. 5. Effective and new methodologies in expediting new product approvals in the U.S. and European Union.
650		0	_aDrug approval _zUnited States
650		0	_aDrugs _xTesting _xStandards
650		0	_aDrugs _xTesting _xGovernment policy _zUnited States
650		0	_aNew products _xGovernment policy _zUnited States
650		2	_aClinical Trials as Topic _xstandards _zUnited States
650		2	_aDrug Evaluation _xstandards _zUnited States
650		2	_aDrug Approval _xstandards _zUnited States
700	1		_aGuarino, Richard A., _d1935-, _eeditor.
830		0	_tDrugs and the pharmaceutical sciences
942			_2ddc _cBK