{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T14:24:08Z","timestamp":1787408648479,"version":"build-2736575974"},"reference-count":21,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:00:00Z","timestamp":1785110400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:00:00Z","timestamp":1785110400000},"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":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Bridging studies are often waived for orphan diseases such as multiple myeloma (MM) due to challenges in conducting clinical trials in small and heterogeneous populations. However, demographic and regional differences between trial participants and Asian populations may influence drug exposure and response. This study evaluated potential differences in drug exposure and response between multinational clinical trial populations (TP) and the Korean patients (KP). Representative drugs from major MM treatment classes were selected based on the available population pharmacokinetic models. Covariate distributions were compared between TP and KP using clinical trial data and Korean real\u2010world data. Simulations were conducted to assess differences in key exposure metrics. Efficacy and safety were evaluated for drugs showing \u2265\u200910% differences in exposure. Simulated carfilzomib exposure was approximately 12%\u201315% lower in KP than in TP across two dosing regimens, corresponding to an estimated 4%\u20139% lower predicted overall response rate based on the published exposure\u2013response data. Conversely, simulated lenalidomide exposure was approximately 25% higher in KP, corresponding to an approximately 1.27\u2010fold higher estimated probability of grade \u2265\u20093 hematologic adverse events. No meaningful exposure differences were observed for daratumumab, melphalan, or panobinostat. These findings suggest that demographic and regional differences between TP and KP may translate into measurable differences in predicted drug exposure for selected multiple myeloma therapies. Simulation\u2010based approaches integrating real\u2010world demographic data may help prioritize drugs or indications that warrant further pharmacokinetic evaluation or focused bridging studies in Korean or broader East Asian populations.<\/jats:p>","DOI":"10.1111\/cts.70664","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T05:04:23Z","timestamp":1785215063000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Simulation\u2010Based Assessment of Dosage Regimen Appropriateness for Multiple Myeloma Medicines Reflecting Demographic and Ethnic Differences"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7591-3646","authenticated-orcid":false,"given":"Minji","family":"Kang","sequence":"first","affiliation":[{"name":"Department of Pharmacology, College of Medicine The Catholic University of Korea  Seoul Republic of Korea"},{"name":"Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, the Catholic University of Korea  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5438-7819","authenticated-orcid":false,"given":"Suein","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, College of Medicine The Catholic University of Korea  Seoul Republic of Korea"},{"name":"Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, the Catholic University of Korea  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung\u2010Soo","family":"Park","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Internal Medicine, College of Medicine The Catholic University of Korea  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sungpil","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, College of Medicine The Catholic University of Korea  Seoul Republic of Korea"},{"name":"Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, the Catholic University of Korea  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seunghoon","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, College of Medicine The Catholic University of Korea  Seoul Republic of Korea"},{"name":"Pharmacometrics Institute for Practical Education and Training (PIPET), College of Medicine, the Catholic University of Korea  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,27]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Regulation on Designation of Orphan Drugs","author":"M.o.F.a.D. 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