000			01857cam a22003974a 4500
999			_c4445 _d4445
001			86113099
003			OCoLC
005			20180516102219.0
008			070314s2007 nyua bf 001 0 eng
010			_a2007010944
015			_aGBA747631 _2bnb
020			_a9780849303951 (hardcover : alk. paper)
020			_a0849303958 (hardcover : alk. paper)
020			_a0849383595
020			_a9780849383595
035			_a(OCoLC)86113099 _z(OCoLC)149062089 _z(OCoLC)174132045
040			_aDNLM/DLC _cDLC _dNLM _dBAKER _dBTCTA _dC#P _dYDXCP _dUKM _dMXC
042			_apcc
050	0	0	_aRM301.45 _b.N53 2007
060	1	0	_aW1 _bDR893B v.171 2007
060	1	0	_aQV 38 _bN577h 2007
082	0	0	_a615.7 _222
100	1		_aNiazi, Sarfaraz, _d1949-
245	1	0	_aHandbook of bioequivalence testing / _cSarfaraz K. Niazi
250			_a1st ed.
260			_aNew York : _bInforma Healthcare USA, _cc2007
300			_axiv, 569 p. : _bill. ; _c27 cm
440		0	_aDrugs and the pharmaceutical sciences ; _vv. 171
504			_aIncludes bibliographical references and index
505	0		_aBioequivalence testing rationale and principles -- Regulatory aspect of bioequivalence testing -- Pharmacokinetic and pharmacodynamic modeling -- Waiver of bioavailability/bioequivalence studies -- Regulatory review process -- Statistical evaluation of bioequivalence data -- Physicochemical properties affecting bioequivalence -- Drug delivery factors -- Bioanalytical method validation -- Good clinical practice -- Good laboratory practice for nonclinical laboratory studies -- Computer and software validation -- Bioequivalence reports
650		0	_aDrugs _xTherapeutic equivalency _vHandbooks, manuals, etc
650	1	2	_aTherapeutic Equivalency _zUnited States
650	2	2	_aDrug Approval _zUnited States
650	2	2	_aModels, Statistical _zUnited States
942			_2ddc _cBK