LEADER 01626nam 2200409Ia 450 001 9910698136903321 005 20090320123831.0 035 $a(CKB)5470000002395613 035 $a(OCoLC)316535700 035 $a(EXLCZ)995470000002395613 100 $a20090320d2008 ua 0 101 0 $aeng 135 $aurbn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aEvaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter$b[electronic resource] 210 1$a[Rockville, Md.?] :$c[U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] 215 $a10 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on Mar. 20, 2009). 300 $a"Current step 2 version 1, dated 13 November 2008." 300 $a"Draft consensus guideline." 300 $a"Q4B annex 8." 320 $aIncludes bibliographical references (page 2). 517 3 $aICH regions on Sterility Test General Chapter 517 1 $aQ4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions 606 $aDrug monitoring 606 $aDrugs$xMicrobiology$xTesting 615 0$aDrug monitoring. 615 0$aDrugs$xMicrobiology$xTesting. 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698136903321 996 $aEvaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter$93180133 997 $aUNINA