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Herein, the experiences that have emerged based on the safety data of classic liposomal formulations in the space of oncology are discussed, along with a description of the new challenges that need to be addressed according to the rapid expansion of nanomedicine platform beyond liposomes. It is valuable to consider the combined use of predictive toxicological assessment supported by deliberate investigation on aspects such as absorption, distribution, metabolism, and excretion (ADME) and toxicokinetic profiles, the risk that may be introduced during nanomanufacture, unique nanomaterials properties, and nonobvious nanosafety endpoints, for example. These efforts will allow the generation of investigational new drug\u2010enabling safety data that can be incorporated into a rational infrastructure for regulatory decision\u2010making. Since the safety assessment relates to nanomaterials, the investigation should cover the important physicochemical properties of the material that may lead to hazards when the nanomedicine product is utilized in humans.<\/jats:p>","DOI":"10.1002\/smll.202000673","type":"journal-article","created":{"date-parts":[[2020,5,14]],"date-time":"2020-05-14T09:35:32Z","timestamp":1589448932000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":77,"title":["Safety Considerations of Cancer Nanomedicine\u2014A Key Step toward Translation"],"prefix":"10.1002","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5719-2838","authenticated-orcid":false,"given":"Xiangsheng","family":"Liu","sequence":"first","affiliation":[{"name":"Division of NanoMedicine Department of Medicine University of California  Los Angeles CA 90095 USA"},{"name":"California NanoSystems Institute University of California  Los Angeles CA 90095 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivanna","family":"Tang","sequence":"additional","affiliation":[{"name":"Division of NanoMedicine Department of Medicine University of California  Los Angeles CA 90095 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zev A.","family":"Wainberg","sequence":"additional","affiliation":[{"name":"Division of Hematology Oncology Department of Medicine University of California  Los Angeles CA 90095 USA"},{"name":"Jonsson Comprehensive Cancer Center University of California  Los Angeles CA 90095 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8844-3938","authenticated-orcid":false,"given":"Huan","family":"Meng","sequence":"additional","affiliation":[{"name":"Division of NanoMedicine Department of Medicine University of California  Los Angeles CA 90095 USA"},{"name":"California NanoSystems Institute University of California  Los Angeles CA 90095 USA"},{"name":"Jonsson Comprehensive Cancer Center University of California  Los Angeles CA 90095 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,14]]},"reference":[{"key":"e_1_2_7_1_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11426-018-9397-5"},{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2217\/nnm.12.87"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsnano.5b03569"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/adma.201606628"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.accounts.9b00126"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.gt.3301923"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.7150\/thno.14858"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/wnan.1438"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2018.00228"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.2174\/1389450115666140804124808"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/adma.201805391"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/smll.201201229"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2006.09.019"},{"key":"e_1_2_7_14_1","unstructured":"https:\/\/www.fda.gov\/media\/109910\/downloadDrug(accessed: January 2020)."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-5173(97)00135-X"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.15226\/2374-6866\/1\/1\/00109"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/nyas.12403"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/btm2.10003"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics9020012"},{"key":"e_1_2_7_20_1","first-page":"742","volume":"42","author":"Ventola C. 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