{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T15:49:29Z","timestamp":1791992969681,"version":"4.4.0"},"reference-count":23,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T00:00:00Z","timestamp":1752537600000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"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":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>In developing a new drug, studies to evaluate the food effect (FE) on the drug's pharmacokinetics (FE studies) are generally conducted in healthy subjects in the early stages of clinical development. Conversely, for anticancer drugs, which have many adverse effects, it is assumed that FE studies cannot be conducted in healthy subjects. However, many unknowns exist about how FE on oral anticancer drugs is examined in clinical development. In this study, we aimed to examine the characteristics of conducting FE studies on anticancer drugs approved in Japan to date. Between 2001 and 2022, 70 new oral anticancer drugs had been approved in Japan. Of the 70 drugs, 67 (95.7%) were subjected to FE studies. Ninety\u2010five FE studies were conducted on these 67 oral anticancer drugs. Sixty\u2010three studies (66.3%) were conducted on (1) healthy subjects. Most studies were (2) single\u2010dose, (3) single\u2010dosage arm, (4) nonrandomized, (5) crossover, and (6) with a sample size of 11\u201330 cases. In addition, 80 (84.2%) of the FE studies were conducted ex\u2010Japan, not in Japan. Furthermore, the results of the chi\u2010square test indicated that \u201c(1) drugs using ex\u2010Japan clinical data\u201d \u201c(2) drugs other than cytotoxic anticancer drugs\u201d \u201c(3) drugs developed ex\u2010Japan\u201d and \u201c(4) drugs with &gt;\u2009100 cases in pivotal trials\u201d were more likely to be subjected to FE studies. In conclusion, in FE studies, clinical trials in healthy subjects rather than patients have already been conducted in response to changes in the modality from cytotoxic drugs to molecular targeted drugs and immune checkpoint inhibitors.<\/jats:p>","DOI":"10.1111\/cts.70304","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T12:09:20Z","timestamp":1752581360000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-5287-0956","authenticated-orcid":false,"given":"Maho","family":"Shibuya","sequence":"first","affiliation":[{"name":"Regulatory Science Faculty of Pharmacy, Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayataka","family":"Kubota","sequence":"additional","affiliation":[{"name":"Regulatory Science Faculty of Pharmacy, Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0117-3961","authenticated-orcid":false,"given":"Hideki","family":"Maeda","sequence":"additional","affiliation":[{"name":"Regulatory Science Faculty of Pharmacy, Meiji Pharmaceutical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0832-z"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-008-9020-0"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpb.2016.11.034"},{"key":"e_1_2_9_5_1","first-page":"775","article-title":"New Oral Anti\u2010Cancer Drugs and Medication Safety","volume":"116","author":"Schlichtig K.","year":"2019","journal-title":"Deutsches \u00c4rzteblatt International"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12967-018-1710-5"},{"key":"e_1_2_9_7_1","unstructured":"FDA \u201cGuidance for Industry Food\u2010Effect Bioavailability and Fed Bioequivalence Studies \u201d(2025) https:\/\/www.fda.gov\/files\/drugs\/published\/Food\u2010Effect\u2010Bioavailability\u2010and\u2010Fed\u2010Bioequivalence\u2010Studies.pdf."},{"key":"e_1_2_9_8_1","unstructured":"Ministry of Health Labour and Welfare \u201cClinical Pharmacology Studies of Drugs \u201d(2025) 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\u201cFood\u2010Effect Studies in New Drug Development: Considerations on Study Designs Based on an Analysis of Recent New Drug Applications in Japan \u201d(2025) https:\/\/www.jstage.jst.go.jp\/article\/rsmp\/12\/2\/12_125\/_pdf\/\u2010char\/ja."},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu500"},{"key":"e_1_2_9_21_1","unstructured":"Ministry of Health Labour and Welfare \u201cBiowaiver Guidelines Based on the Biopharmaceutics Classification System (BCS) \u201d(2025) https:\/\/www.pmda.go.jp\/files\/000238767.pdf."},{"key":"e_1_2_9_22_1","unstructured":"Ministry of Health Labour and Welfare \u201cReport of the Study Group on the Ideal State of Pharmaceutical Regulations for Strengthening Drug Discovery and Ensuring Stable Supply etc. \u201d(2025) 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