{"title":"生物仿制药的科学--更新互换性","authors":"Patrizia Cavazzoni, Sarah Yim","doi":"10.1001/jama.2024.15225","DOIUrl":null,"url":null,"abstract":"This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Science of Biosimilars—Updating Interchangeability\",\"authors\":\"Patrizia Cavazzoni, Sarah Yim\",\"doi\":\"10.1001/jama.2024.15225\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.\",\"PeriodicalId\":518009,\"journal\":{\"name\":\"JAMA\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-09-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1001/jama.2024.15225\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/jama.2024.15225","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
美国食品和药物管理局 (FDA) 的这一观点总结了 FDA 最近对有关临床转换研究必要性的互换性指南草案的更新，以说明 FDA 正在努力简化生物类似药的开发，使其符合最新的科学发展。
The Science of Biosimilars—Updating Interchangeability
This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.
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