{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T17:58:27Z","timestamp":1761674307199},"reference-count":36,"publisher":"Pharmaceutical Society of Japan","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["YAKUGAKU ZASSHI"],"published-print":{"date-parts":[[2021,1,1]]},"DOI":"10.1248\/yakushi.20-00148","type":"journal-article","created":{"date-parts":[[2020,12,31]],"date-time":"2020-12-31T22:23:33Z","timestamp":1609453413000},"page":"111-124","source":"Crossref","is-referenced-by-count":1,"title":["Current Issues in Photosafety Evaluation","\u5149\u5b89\u5168\u6027\u8a55\u4fa1\u306e\u73fe\u72b6\u3068\u8ab2\u984c"],"prefix":"10.1248","volume":"141","author":[{"given":"Satomi","family":"Onoue","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Sciences, University of Shizuoka"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Kouzuki","sequence":"additional","affiliation":[{"name":"Shiseido Global Innovation Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akemi","family":"Toyoda","sequence":"additional","affiliation":[{"name":"POLA Chemical Industries, Inc. (Japan Cosmetic Industry Association)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Fueki","sequence":"additional","affiliation":[{"name":"Pharmaceuticals and Medical Devices Agency"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Hosoi","sequence":"additional","affiliation":[{"name":"Santen Pharmaceutical Co., Ltd."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hajime","family":"Kojima","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takao","family":"Ashikaga","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Onodera","sequence":"additional","affiliation":[{"name":"National Institute of Health Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"163","reference":[{"key":"1","unstructured":"1) Organization for Economic Cooperation and Development (OECD), \u201cOECD Guidelines for the Testing of Chemicals, Section 4, Test No. 432: <i>In Vitro<\/i> 3T3 NRU Phototoxicity Test,\u201d 2019: \u3008https:\/\/www.oecd-ilibrary.org\/environment\/test-no-432-in-vitro-3t3-nru-phototoxicity-test_9789264071162-en\u3009, cited 19 June, 2020."},{"key":"2","unstructured":"2) International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH guideline S10 Guidance on photosafety evaluation of pharmaceuticals, 2014: \u3008https:\/\/database.ich.org\/sites\/default\/files\/S10_Guideline.pdf\u3009, cited 19 June, 2020."},{"key":"3","doi-asserted-by":"crossref","unstructured":"3) Moore D. E., <i>Mutat. Res.<\/i>, <b>422<\/b>, 165-173 (1998).","DOI":"10.1016\/S0027-5107(98)00189-4"},{"key":"4","doi-asserted-by":"crossref","unstructured":"4) Moore D. E., <i>Drug Saf.<\/i>, <b>25<\/b>, 345-372 (2002).","DOI":"10.2165\/00002018-200225050-00004"},{"key":"5","doi-asserted-by":"crossref","unstructured":"5) Onoue S., Tsuda Y., <i>Pharm. Res.<\/i>, <b>23<\/b>, 156-164 (2006).","DOI":"10.1007\/s11095-005-8497-9"},{"key":"6","unstructured":"6) European Agency for the Evaluation of Medicinal Products (EMEA), Notes for Guidance on Photosafety Testing, 2002: \u3008https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/note-guidance-photosafety-testing_en.pdf.\u3009, cited 19 June, 2020."},{"key":"7","doi-asserted-by":"crossref","unstructured":"7) Jocobs A. C., Brown P. C., Chen C., Ellis A., Farrelly J., Osterberg R., <i>Toxicol. Pathol.<\/i>, <b>32<\/b> (Suppl. 2), 17-18 (2004).","DOI":"10.1080\/01926230490463821"},{"key":"8","doi-asserted-by":"crossref","unstructured":"8) Henry B., Foti C., Alsante K., <i>J. Photochem. Photobiol. B<\/i>, <b>96<\/b>, 57-62 (2009).","DOI":"10.1016\/j.jphotobiol.2009.04.005"},{"key":"9","unstructured":"9) Spielmann H., Liebsch M., D\u00f6ring B., Moldenhauer F., <i>ALTEX<\/i>, <b>11<\/b>, 22-31 (1994)."},{"key":"10","doi-asserted-by":"crossref","unstructured":"10) Lynch A. M., Wilcox P., <i>Exp. Toxicol. Pathol.<\/i>, <b>63<\/b>, 209-214 (2011).","DOI":"10.1016\/j.etp.2009.12.001"},{"key":"11","doi-asserted-by":"crossref","unstructured":"11) Onoue S., Seto Y., Gandy G., Yamada S., <i>Curr. Drug Saf.<\/i>, <b>4<\/b>, 123-136 (2009).","DOI":"10.2174\/157488609788173044"},{"key":"12","doi-asserted-by":"crossref","unstructured":"12) Hoya M., Hirota M., Suzuki M., Hagino S., Itagaki H., Aiba S., <i>Toxicol. in Vitro<\/i>, <b>23<\/b>, 911-918 (2009).","DOI":"10.1016\/j.tiv.2009.03.010"},{"key":"13","doi-asserted-by":"crossref","unstructured":"13) Hino R., Orimo H., Kabashima K., Atarashi K., Nakanishi M., Kuma H., Tokura Y., <i>J. Dermatol. Sci.<\/i>, <b>52<\/b>, 140-143 (2008).","DOI":"10.1016\/j.jdermsci.2008.06.002"},{"key":"14","doi-asserted-by":"crossref","unstructured":"14) Seto Y., Ochi M., Onoue S., Yamada S., <i>J. Pharm. Biomed. Anal.<\/i>, <b>52<\/b>, 781-786 (2010).","DOI":"10.1016\/j.jpba.2010.02.029"},{"key":"15","doi-asserted-by":"crossref","unstructured":"15) Onoue S., Igarashi N., Kitagawa F., Otsuka K., Tsuda Y., <i>J. Chromatogr. A<\/i>, <b>1188<\/b>, 50-56 (2008).","DOI":"10.1016\/j.chroma.2007.09.084"},{"key":"16","doi-asserted-by":"crossref","unstructured":"16) Onoue S., Seto Y., Oishi A., Yamada S., <i>J. Pharm. Sci.<\/i>, <b>98<\/b>, 3647-3658 (2009).","DOI":"10.1002\/jps.21670"},{"key":"17","unstructured":"17) Ministry of Health, Labour and Welfare, PFSB\/ELD Notification No. 0219-4, Guidance on the Implementation of Non-Clinical Safety Studies for Use in Applications for Authorization of Clinical Trials and Marketing for Pharmaceuticals (February 19, 2010): \u3008https:\/\/www.pmda.go.jp\/files\/000156948.pdf\u3009, Pharmaceuticals and Medical Devices Agency (PMDA) Web, cited 19 June, 2020."},{"key":"18","unstructured":"18) Ministry of Health, Labour and Welfare, PFSB\/ELD Notification No. 0521-1, Guidelines for Photosafety Evaluation of Pharmaceuticals (May 21, 2014): \u3008https:\/\/www.pmda.go.jp\/files\/000156697.pdf\u3009, Pharmaceuticals and Medical Devices Agency (PMDA) Web, cited 19 June, 2020."},{"key":"19","unstructured":"19) Boettner E. A., Wolter R., <i>IOVS<\/i>, <b>1<\/b>, 776-783 (1962)."},{"key":"20","unstructured":"20) Ministry of Health, Labour and Welfare, Liaison, Guidance on the Use of Alternative Methods for Testing Skin Sensitization and Phototoxicity in Safety Assessments of Cosmetics and Quasi-drugs (April 26, 2012): \u3008https:\/\/www.pmda.go.jp\/files\/000161377.pdf\u3009, Pharmaceuticals and Medical Devices Agency (PMDA) Web, cited 19 June, 2020."},{"key":"21","doi-asserted-by":"crossref","unstructured":"21) Nishida H., Hirota M., Seto Y., Suzuki G., Kato M., Kitagaki M., Sugiyama M., Kouzuki H., Onoue, S., <i>Regul. Toxicol. Pharmacol.<\/i>, <b>72<\/b>, 578-585 (2015).","DOI":"10.1016\/j.yrtph.2015.05.029"},{"key":"22","doi-asserted-by":"crossref","unstructured":"22) Seto Y., Kato M., Yamada S., Onoue S., <i>Toxicol. in Vitro<\/i>, <b>27<\/b>, 1838-1846 (2013).","DOI":"10.1016\/j.tiv.2013.05.008"},{"key":"23","doi-asserted-by":"crossref","unstructured":"23) Kandarova H., Liebsch M., \u201cAlternatives for Dermal Toxicity Testing, The EpiDerm<sup>TM<\/sup> Phototoxicity Test (EpiDerm<sup>TM<\/sup> H3D-PT),\u201d ed. by Eskes C., van Vliet E., Maibach H. I., Springer International Publishing, New York, 2017, pp. 483-503.","DOI":"10.1007\/978-3-319-50353-0_35"},{"key":"24","unstructured":"24) JaCVAM Phototoxicity Resource Editorial Committee, ROS Assay Evaluation Report, July 8, 2015: \u3008http:\/\/www.jacvam.jp\/files\/news\/20151104_2.pdf\u3009, cited 19 June, 2020."},{"key":"25","doi-asserted-by":"crossref","unstructured":"25) Oeda S., Hirota M. Nishida H., Ashikaga T., Sasa H., Aiba S., Tokura Y., Kouzuki H., <i>J. Toxicol. Sci.<\/i>, <b>41<\/b>, 129-142 (2016).","DOI":"10.2131\/jts.41.129"},{"key":"26","doi-asserted-by":"crossref","unstructured":"26) Tsujita-Inoue K., Hirota M., Atobe T., Ashikaga T., Tokura Y., Kouzuki H., <i>J. Appl. Toxicol.<\/i>, <b>36<\/b>, 956-968 (2016).","DOI":"10.1002\/jat.3234"},{"key":"27","unstructured":"27) Nishida H., Ashikaga T., Hirota M., Onoue S., Seto Y., Kouzuki H., Abstracts of papers, the 55th Annual Meeting for Society of Toxicology, New Orleans, March 2016, Abstract No. 2777."},{"key":"28","unstructured":"28) Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for the Testing of Chemicals Test No. 432. <i>In Vitro<\/i> 3T3 NRU Phototoxicity Test, 2004: \u3008https:\/\/www.oecd.org\/env\/ehs\/testing\/Test%20No.432-2004%20English.pdf\u3009, cited 19 June, 2020."},{"key":"29","doi-asserted-by":"crossref","unstructured":"29) Brunk U. T., Svensson I., <i>Redox Rep.<\/i>, <b>4<\/b>, 3-11 (1999).","DOI":"10.1179\/135100099101534675"},{"key":"30","doi-asserted-by":"crossref","unstructured":"30) Johansson A.-C., Appelqvist H., Nilsson C., K\u00e5gedal K., Roberg K., \u00d6llinger K., <i>Apoptosis<\/i>, <b>15<\/b>, 527-540 (2010).","DOI":"10.1007\/s10495-009-0452-5"},{"key":"31","doi-asserted-by":"crossref","unstructured":"31) Onoue S., Yamauchi Y., Kojima T., Igarashi N., Tsuda Y., <i>Pharm. Res.<\/i>, <b>25<\/b>, 861-868 (2008).","DOI":"10.1007\/s11095-007-9383-4"},{"key":"32","doi-asserted-by":"crossref","unstructured":"32) Onoue S., Kawamura K., Igarashi N., Zhou Y., Fujikawa M., Yamada H., Tsuda Y., Seto Y., Yamada S., <i>J. Pharm. Biomed. Anal.<\/i>, <b>47<\/b>, 967-972 (2008).","DOI":"10.1016\/j.jpba.2008.03.026"},{"key":"33","doi-asserted-by":"crossref","unstructured":"33) Onoue S., Hosoi K., Wakuri S., Iwase Y., Yamamoto T., Matsuoka N., Nakamura K., Toda T., Takagi H., Osaki N., Matsumoto Y., Kawasaki S., Seto Y., Kato M., Yamada S., Ohno Y., Kojima H., <i>J. Appl. Toxicol.<\/i>, <b>33<\/b>, 1241-1250 (2013).","DOI":"10.1002\/jat.2776"},{"key":"34","doi-asserted-by":"crossref","unstructured":"34) Onoue S., Hosoi K., Toda T., Takagi H., Osaki N., Matsumoto Y., Kawakami S., Wakuri S., Iwase Y., Yamamoto T., Nakamura K., Ohno Y., Kojima H., <i>Toxicol. in Vitro<\/i>, <b>28<\/b>, 515-523 (2014).","DOI":"10.1016\/j.tiv.2013.11.014"},{"key":"35","unstructured":"35) Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for the Testing of Chemicals, Section 4, Test No. 495: Ros (Reactive Oxygen Species) Assay for Photoreactivity, 2019: \u3008https:\/\/www.oecd-ilibrary.org\/environment\/tg-495-ros-reactive-oxygen-species-assay-for-photoreactivity_915e00ac-en\u3009, cited 19 June, 2020."},{"key":"36","doi-asserted-by":"crossref","unstructured":"36) Onoue S., Kato M., Inoue R., Seto Y., Yamada S., <i>Toxicol. Sci.<\/i>, <b>137<\/b>, 469-477 (2014).","DOI":"10.1093\/toxsci\/kft260"}],"container-title":["YAKUGAKU ZASSHI"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/yakushi\/141\/1\/141_20-00148\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,28]],"date-time":"2023-10-28T18:14:10Z","timestamp":1698516850000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/yakushi\/141\/1\/141_20-00148\/_article\/-char\/ja\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,1]]},"references-count":36,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.1248\/yakushi.20-00148","relation":{},"ISSN":["0031-6903","1347-5231"],"issn-type":[{"value":"0031-6903","type":"print"},{"value":"1347-5231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,1]]}}}