{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,11,8]],"date-time":"2023-11-08T00:22:47Z","timestamp":1699402967787},"reference-count":5,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,7,21]],"date-time":"2017-07-21T00:00:00Z","timestamp":1500595200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:p>We the authors work in the US Food and Drug Administration (FDA) review division responsible for the therapeutic agents for primary renal disease. We also field consultative inquiries regarding off\u2010target adverse renal effects of drugs intended to treat other diseases. We do neither basic science research on renal diseases nor clinical studies of new drugs, but we are professional spectators of both. We offer here our thoughts on the challenge of identifying renal safety signals in the preclinical space and in the earliest phases of clinical development.<\/jats:p>","DOI":"10.1002\/cpt.745","type":"journal-article","created":{"date-parts":[[2017,7,21]],"date-time":"2017-07-21T09:12:55Z","timestamp":1500628375000},"page":"387-388","source":"Crossref","is-referenced-by-count":2,"title":["Evaluating the Renal Safety of Investigational New Drugs: Where Should We Be Going?"],"prefix":"10.1111","volume":"102","author":[{"given":"N","family":"Stockbridge","sequence":"first","affiliation":[{"name":"US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Blank","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"EA","family":"Hausner","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"Thompson","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,7,21]]},"reference":[{"key":"e_1_2_5_1_1","unstructured":"The US Food and Drug Administration. <https:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DrugDevelopmentToolsQualification Program\/UCM382536.pdf>."},{"key":"e_1_2_5_2_1","unstructured":"The US Food and Drug Administration. <https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DrugDevelopmentToolsQualification Program\/BiomarkerQualificationProgram\/default.htm>."},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.1627"},{"key":"e_1_2_5_4_1","unstructured":"The US Food and Drug Administration. <https:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DrugDevelopmentToolsQualification Program\/UCM285031.pdf>."},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.606"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpt.745","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.745","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,7]],"date-time":"2023-11-07T13:35:34Z","timestamp":1699364134000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.745"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,7,21]]},"references-count":5,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2017,9]]}},"alternative-id":["10.1002\/cpt.745"],"URL":"https:\/\/doi.org\/10.1002\/cpt.745","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,7,21]]}}}