{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T14:04:18Z","timestamp":1778508258165,"version":"3.51.4"},"reference-count":13,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T00:00:00Z","timestamp":1748476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["24K13399"],"award-info":[{"award-number":["24K13399"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:p>More than 30 anti\u2010HIV drugs have been approved in Japan using data from dossiers submitted to the United States or European regulatory authorities since 1998. These drugs were approved with the same dosage and administration regimes as in the United States and Europe, using data from pivotal studies that rarely included any Japanese patients, whereas pharmacokinetics (PK) studies in Japanese subjects have been previously required by the Japanese authorities. There have not been any clinically meaningful ethnic differences observed in the PK data from Japanese studies, and no issues with efficacy or safety have been identified as these drugs were marketed. The absence of ethnic differences in PK, efficacy and safety data for over 30 anti\u2010HIV medicines has reached the state of \u2018the need for bridging data will lessen with experience\u2019 in ICH\u2010E5. It may not be necessary to consider biological ethnic differences in the approval of anti\u2010HIV drugs anymore.<\/jats:p>","DOI":"10.1002\/bcp.70100","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T05:53:21Z","timestamp":1748498001000},"page":"2474-2479","source":"Crossref","is-referenced-by-count":1,"title":["Consideration of ethnic differences in approvals for anti\u2010HIV medicines in Japan: Evaluation based on pharmacokinetic studies and post\u2010marketing data"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8326-8835","authenticated-orcid":false,"given":"Rumiko","family":"Shimazawa","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology Tokai University School of Medicine  Isehara Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5157-1362","authenticated-orcid":false,"given":"Masayuki","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics Kagawa University Hospital  Miki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,5,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2409392"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2022.1084980"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aax2550"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/scientificamerican0807-40"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/2042098617743393"},{"key":"e_1_2_8_7_1","unstructured":"Ministry of Health and Welfare Pharmaceutical Safety Bureau Review Management Division Director Notice.Regarding the handling of applications for manufacturing or import approval of drugs for the treatment of HIV infection November 12 1998. Pharmaceutical Review No 1015 (in Japanese). Accessed April 18 2025.https:\/\/www.osakayakugaihiv.org\/10-9"},{"issue":"2","key":"e_1_2_8_8_1","first-page":"78","article-title":"The current status and trends of HIV infection in Japan","volume":"17","author":"Kamakura M","year":"2015","journal-title":"J AIDS Res"},{"key":"e_1_2_8_9_1","unstructured":"Ministry of Health Labour and Welfare (MHLW).Basic principles on global clinical trials.2007. Accessed November 29 2024.https:\/\/www.pmda.go.jp\/files\/000153265.pdf"},{"key":"e_1_2_8_10_1","unstructured":"Ministry of Health Labour and Welfare (MHLW).Basic principles on global clinical trials (reference cases).2012. Accessed November 29 2024.https:\/\/www.pmda.go.jp\/files\/000157520.pdf"},{"key":"e_1_2_8_11_1","unstructured":"Ministry of Health Labour and Welfare (MHLW).Basic principles for conducting phase I trials in the Japanese population prior to global clinical trials.2014. 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