Drug-drug in­ter­ac­tions: FDA is­sues guid­ance on clin­i­cal, in vit­ro stud­ies

The FDA on Thurs­day fi­nal­ized two guid­ances pro­vid­ing rec­om­men­da­tions to drug­mak­ers on eval­u­at­ing po­ten­tial drug-drug in­ter­ac­tions (DDIs) for new drugs through clin­i­cal and in vit­ro test­ing.

“To­geth­er, the two fi­nal guid­ances de­scribe a sys­tem­at­ic risk-based ap­proach to eval­u­a­tion and com­mu­ni­ca­tion of DDIs,” the FDA writes.

The two guid­ances fi­nal­ize draft ver­sions re­leased in 2017 and have been re­vised to clar­i­fy their scope, pro­vide ad­di­tion­al con­sid­er­a­tions for con­duct­ing prospec­tive stud­ies and to ex­plain “when DDI stud­ies are need­ed for drugs iden­ti­fied as trans­porter sub­strates from in vit­ro stud­ies.” Both guid­ances have been re­named from their draft ver­sions to re­flect an em­pha­sis on in­ves­ti­gat­ing the cy­tochrome P450 (CYP) en­zyme and trans­porter-me­di­at­ed drug in­ter­ac­tions.

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