FDA sees success in model-informed drug development pilot

Con­sult­ing the FDA on us­ing math­e­mat­i­cal sim­u­la­tions in drug de­vel­op­ment could make the process more ef­fi­cient, sav­ing spon­sors time and mon­ey, a re­port on the agency’s pi­lot pro­gram on mod­el-in­formed drug de­vel­op­ment con­clud­ed.

Four of­fi­cials in the Of­fice of Clin­i­cal Phar­ma­col­o­gy who led the pi­lot au­thored a re­port pub­lished Wednes­day on the agency’s Mod­el-In­formed Drug De­vel­op­ment (MIDD) pi­lot, a pro­gram spear­head­ed by the Cen­ter for Drug Eval­u­a­tion and Re­search that gave spon­sors ad­di­tion­al ac­cess to re­view­ers to get an­swers on how to use math­e­mat­i­cal mod­els in their drug tri­als. The pi­lot was es­tab­lished as part of the sixth it­er­a­tion of the Pre­scrip­tion Drug User Fee Act, which was im­ple­ment­ed in 2018.

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