LEADER 01310nam 2200373Ia 450 001 9910696977703321 005 20230902161909.0 035 $a(CKB)5470000002383112 035 $a(OCoLC)535506920 035 $a(EXLCZ)995470000002383112 100 $a20100302d2008 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $egenotoxic and carcinogenic impurities in drug substances and products, recommended approaches 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[2008] 215 $a1 online resource (13 pages) $cchart 300 $a"Draft guidance." 300 $a"Pharmacology and toxicology." 300 $a"December 2008." 517 $aGuidance for industry 606 $aGenetic toxicology$zUnited States 606 $aDrugs$xCarcinogenicity$zUnited States 615 0$aGenetic toxicology 615 0$aDrugs$xCarcinogenicity 712 02$aCenter for Drug Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910696977703321 996 $aGuidance for industry$93434577 997 $aUNINA