{"title":"大流行中的剂量选择:FDA动物规则提供的框架。","authors":"Kunyi Wu, Kimberly L Bergman","doi":"10.1111/cts.12936","DOIUrl":null,"url":null,"abstract":"Effective treatment approaches in a pandemic such as COVID-19 hinge on expeditious identification of sound dosing strategies. Informed by experience with the Food and Drug Administration (FDA) Animal Rule, this commentary illustrates a framework for leveraging and integrating clinical pharmacology information for dose selection to treat novel infections in a public health emergency setting.","PeriodicalId":501617,"journal":{"name":"Clinical and Translational Science","volume":" ","pages":"5-7"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1111/cts.12936","citationCount":"1","resultStr":"{\"title\":\"Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule.\",\"authors\":\"Kunyi Wu, Kimberly L Bergman\",\"doi\":\"10.1111/cts.12936\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Effective treatment approaches in a pandemic such as COVID-19 hinge on expeditious identification of sound dosing strategies. Informed by experience with the Food and Drug Administration (FDA) Animal Rule, this commentary illustrates a framework for leveraging and integrating clinical pharmacology information for dose selection to treat novel infections in a public health emergency setting.\",\"PeriodicalId\":501617,\"journal\":{\"name\":\"Clinical and Translational Science\",\"volume\":\" \",\"pages\":\"5-7\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1111/cts.12936\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Science\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/cts.12936\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/12/16 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/cts.12936","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/12/16 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule.
Effective treatment approaches in a pandemic such as COVID-19 hinge on expeditious identification of sound dosing strategies. Informed by experience with the Food and Drug Administration (FDA) Animal Rule, this commentary illustrates a framework for leveraging and integrating clinical pharmacology information for dose selection to treat novel infections in a public health emergency setting.