LEADER 03319nam 2200685Ia 450 001 9911107635103321 005 20251017110113.0 010 $a0-309-14231-8 010 $a1-282-27265-9 010 $a9786612272653 010 $a0-309-13125-1 035 $a(CKB)1000000000789198 035 $a(OCoLC)427878159 035 $a(CaPaEBR)ebrary10327027 035 $a(SSID)ssj0000096382 035 $a(PQKBManifestationID)11121580 035 $a(PQKBTitleCode)TC0000096382 035 $a(PQKBWorkID)10076939 035 $a(PQKB)10857566 035 $a(MiAaPQ)EBC3378514 035 $a(Au-PeEL)EBL3378514 035 $a(CaPaEBR)ebr10327027 035 $a(CaONFJC)MIL227265 035 $a(OCoLC)923280588 035 $a(DNLM)1518373 035 $a(EXLCZ)991000000000789198 100 $a20090819d2009 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aAccelerating the development of biomarkers for drug safety $eworkshop summary /$fSteve Olson, Sally Robinson and Robert Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2009 215 $a1 online resource (99 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a0-309-13124-3 320 $aIncludes bibliographical references (p. 55-57). 327 $aOverview Of key issues -- Cardiac safety biomarkers -- Assessing and predicting kidney safety -- Biomarkers of acute idiosyncratic hepatocellular injury in clinical trials -- Future considerations. 330 $a"Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held 'Assessing and Accelerating Development of Biomarkers for Drug Safety,' a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development."--Publisher's website. 606 $aBiochemical markers$vCongresses 606 $aDrugs$xSafety measures$vCongresses 606 $aDrugs$xTesting$vCongresses 615 0$aBiochemical markers 615 0$aDrugs$xSafety measures 615 0$aDrugs$xTesting 676 $a616.075 701 $aGiffin$b Robert B$01920977 701 $aOlson$b Steve$f1956-$0488724 701 $aRobinson$b Sally$0620917 712 02$aNational Research Council (U.S.).$bPlanning Committee for Assessing and Accelerating the Development of Biomarkers for Drug Safety : a Workshop. 712 12$aAssessing and Accelerating the Development of Biomarkers for Drug Safety. Workshop$f(2008 :$eWashington, D.C.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911107635103321 996 $aAccelerating the development of biomarkers for drug safety$94768312 997 $aUNINA