{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T13:13:17Z","timestamp":1789996397872,"version":"4.0.1"},"reference-count":43,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Addressing knowledge gaps at drug approval through drug\u2013drug interaction (DDI)\u2010related postmarketing requirements (PMRs) and commitments (PMCs) is essential for safe and effective use. This analysis reviewed CYP3A\u2010related PMRs and PMCs, the most evaluated enzyme in postmarketing studies, to characterize their scope. CYP3A\u2010related PMRs, PMCs, and labeling recommendations were identified for small\u2010molecule new molecular entities approved by the U.S. Food and Drug Administration (2015\u20132024) using the Certara Drug Interaction Database (DIDB). The latest product labels from Drugs@FDA were reviewed for updates. Drugs were categorized as CYP3A substrates, inhibitors, or inducers based on PMR\/PMC language. Of 332 approved drugs, 51 (15%) had CYP3A\u2010related PMRs\/PMCs, totaling 91 studies (53 PMRs, 37 PMCs, and 1 unspecified). About two\u2010thirds were oncology drugs, including 25 kinase inhibitors. As substrates, 37 drugs had 65 requests: 26 with inhibitors (all PMRs) and 39 with inducers (30 PMCs, 8 PMRs, and 1 unspecified); 20 included physiologically based pharmacokinetic (PBPK) modeling. As precipitants, 25 drugs had 26 requests: 12 as inhibitors (11 PMRs, 1 PMC), 14 as inducers (8 PMRs, 6 PMCs), with only 1 PBPK option. Requests most often involved studies with a CYP3A substrate (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200924), moderate inducer (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200921), strong inducer (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200915), strong inhibitor (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200910), and moderate inhibitor (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u20099). Initial labeling recommendations were issued for 60 studies (65%; 35 drugs), and 53 studies (58%; 29 drugs) resulted in label updates. Overall, CYP3A\u2010mediated DDIs remain a key focus of postmarketing evaluation, particularly for oncology drugs. PMRs and PMCs are critical for resolving uncertainties and informing label updates.\n                  <\/jats:p>","DOI":"10.1111\/cts.70729","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:51:22Z","timestamp":1789649482000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Understanding Postmarketing Requirements and Commitments for\n                    <scp>CYP3A<\/scp>\n                    \u2010Mediated Drug\u2013Drug Interactions: An Analysis of\n                    <scp>FDA<\/scp>\n                    \u2010Approved Drugs From 2015 to 2024"],"prefix":"10.1111","volume":"19","author":[{"given":"Jingjing","family":"Yu","sequence":"first","affiliation":[{"name":"Drug Interaction Solutions, Certara  Radnor Pennsylvania USA"},{"name":"Drug Interaction Science Innovation Engine, Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiko","family":"Petrie","sequence":"additional","affiliation":[{"name":"Drug Interaction Solutions, Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Argon","sequence":"additional","affiliation":[{"name":"Drug Interaction Solutions, Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Owens","sequence":"additional","affiliation":[{"name":"Drug Interaction Solutions, Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Ragueneau\u2010Majlessi","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics School of Pharmacy, University of Washington  Seattle Washington 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