000 01751 a2200469 4500
005 20250515104212.0
264 0 _c20080519
008 200805s 0 0 eng d
022 _a0091-2700
024 7 _a10.1177/0091270007311111
_2doi
040 _aNLM
_beng
_cNLM
100 1 _aWang, Yaning
245 0 0 _aLeveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
_h[electronic resource]
260 _bJournal of clinical pharmacology
_cFeb 2008
300 _a146-56 p.
_bdigital
500 _aPublication Type: Journal Article
650 0 4 _aClinical Trials as Topic
_xmethods
650 0 4 _aDecision Making
650 0 4 _aDrug Approval
_xlegislation & jurisprudence
650 0 4 _aDrug Industry
_xlegislation & jurisprudence
650 0 4 _aGovernment Regulation
650 0 4 _aGuidelines as Topic
650 0 4 _aHumans
650 0 4 _aInvestigational New Drug Application
_xlegislation & jurisprudence
650 0 4 _aLegislation, Drug
_xstandards
650 0 4 _aOrganizational Objectives
650 0 4 _aTime Factors
650 0 4 _aUnited States
650 0 4 _aUnited States Food and Drug Administration
_xlegislation & jurisprudence
700 1 _aBhattaram, A Venkatesh
700 1 _aJadhav, Pravin R
700 1 _aLesko, Lawrence J
700 1 _aMadabushi, Rajanikanth
700 1 _aPowell, J Robert
700 1 _aQiu, Wei
700 1 _aSun, He
700 1 _aYim, Dong S
700 1 _aZheng, Jenny J
700 1 _aGobburu, Jogarao V S
773 0 _tJournal of clinical pharmacology
_gvol. 48
_gno. 2
_gp. 146-56
856 4 0 _uhttps://doi.org/10.1177/0091270007311111
_zAvailable from publisher's website
999 _c17707989
_d17707989