LEADER 01541oam 2200421Ia 450 001 9910698139103321 005 20100112152118.0 035 $a(CKB)5470000002395591 035 $a(OCoLC)316342011 035 $a(EXLCZ)995470000002395591 100 $a20090319d2009 ua 0 101 0 $aeng 135 $aurbn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eclinical pharmacology section of labeling for human prescription drug and biological products : content and format 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) :$cCenter for Biologics Evaluation and Research (CBER),$d[2009] 215 $a11 pages $cdigital, PDF file 300 $aTitle from title screen (viewed on Mar. 19, 2009). 300 $a"Draft guidance." 300 $a"February 2009." 517 $aGuidance for industry 606 $aDrugs$xLabeling$zUnited States 606 $aBiological products$xLabeling$zUnited States 615 0$aDrugs$xLabeling 615 0$aBiological products$xLabeling 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 801 2$bGPO 801 2$bCDS 801 2$bGPO 906 $aBOOK 912 $a9910698139103321 996 $aGuidance for industry$93434577 997 $aUNINA