LEADER 01369nam 2200397Ia 450 001 9910699222303321 005 20230902161906.0 035 $a(CKB)5470000002401686 035 $a(OCoLC)493493259 035 $a(EXLCZ)995470000002401686 100 $a20091223d2009 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aAddendum to ICH S6$b[electronic resource] $epreclinical safety evaluation of biotechnology-derived pharmaceuticals 210 1$a[Rockville, Md.?] :$c[U.S. Dept. of Health and Human Services, Food and Drug Administration],$d[2009] 215 $a1 online resource (iv, 14 pages) 300 $a"ICH harmonised tripartite guideline." 300 $a"S6(R1)." 300 $a"Current step 2 version, dated October 29, 2009." 320 $aIncludes bibliographical references (page 14). 517 $aAddendum to ICH S6 606 $aPharmaceutical biotechnology 606 $aDrugs$xTesting 615 0$aPharmaceutical biotechnology. 615 0$aDrugs$xTesting. 712 02$aUnited States.$bFood and Drug Administration. 712 12$aInternational Conference on Harmonisation. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910699222303321 996 $aAddendum to ICH S6$93518709 997 $aUNINA