01777nas a2200313   4500000000100000008004100001260001500042100002300057700001800080700001800098700002800116700003200144700002000176700002200196700001900218700002000237700001900257700002300276700002300299700002200322700002000344700002400364245007400388856007200462300001200534490000700546520089600553022001401449       2019                            d  c2019-02-011 aElizabeth J. Baker1 aNancy A. Beck1 aEllen L. Berg1 aHelene D. Clayton-Jeter1 aP. Charukeshi Chandrasekera1 aJ. Lowry Curley1 aBruce A. Donzanti1 aLorna C. Ewart1 aJane M. Gunther1 aJ. Gerry Kenna1 aEdward L. LeCluyse1 aMichael N. Liebman1 aCatherine L. Pugh1 aPaul B. Watkins1 aKristie M. Sullivan00aAdvancing nonclinical innovation and safety in pharmaceutical testing  uhttps://www.sciencedirect.com/science/article/pii/S1359644618302642  a624-6280 v243 aNonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silico methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes. Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-based approaches.  a1359-6446