{"title":"无偏见的安全审查委员会在 I 期临床试验中的重要性","authors":"Gerald L. Klein, Roger Morgan","doi":"10.17140/ctpoj-6-e002","DOIUrl":null,"url":null,"abstract":"Conducting clinical trials is the process that biopharmaceutical companies must use to demonstrate that their product is safe, well-tolerated, and efficacious to obtain marketing approval from the Food and Drug Administration (FDA)","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":" 44","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials\",\"authors\":\"Gerald L. Klein, Roger Morgan\",\"doi\":\"10.17140/ctpoj-6-e002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Conducting clinical trials is the process that biopharmaceutical companies must use to demonstrate that their product is safe, well-tolerated, and efficacious to obtain marketing approval from the Food and Drug Administration (FDA)\",\"PeriodicalId\":259842,\"journal\":{\"name\":\"Clinical Trials and Practice – Open Journal\",\"volume\":\" 44\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-12-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Trials and Practice – Open Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17140/ctpoj-6-e002\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Trials and Practice – Open Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17140/ctpoj-6-e002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials
Conducting clinical trials is the process that biopharmaceutical companies must use to demonstrate that their product is safe, well-tolerated, and efficacious to obtain marketing approval from the Food and Drug Administration (FDA)