{"title":"放射性药物良好实践：医院和行业之间的监管","authors":"Alain Faivre-Chauvet, Cécile Bourdeau, Mickaël Bourgeois","doi":"10.3389/fnume.2022.990330","DOIUrl":null,"url":null,"abstract":"<p><p>Radiopharmaceutical practices are divided into large-scale industrial manufacturing and small-scale \"in-house\" hospital radiopharmacy unit. The recent evolution of nuclear medicine involves deep consequences in this ever-present regulatory state, and hospital radiopharmacy units cannot be considered as contract manufacturing organizations (CMO). This review provides an updated status report of the official (and non-official) guidelines supporting the regulations required to meet hospital and industry common radiopharmaceutical manufacturing standards to facilitate the current and future innovative radiopharmaceutical development.</p>","PeriodicalId":73095,"journal":{"name":"Frontiers in nuclear medicine (Lausanne, Switzerland)","volume":" ","pages":"990330"},"PeriodicalIF":0.0000,"publicationDate":"2022-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440975/pdf/","citationCount":"0","resultStr":"{\"title\":\"Radiopharmaceutical good practices: Regulation between hospital and industry.\",\"authors\":\"Alain Faivre-Chauvet, Cécile Bourdeau, Mickaël Bourgeois\",\"doi\":\"10.3389/fnume.2022.990330\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Radiopharmaceutical practices are divided into large-scale industrial manufacturing and small-scale \\\"in-house\\\" hospital radiopharmacy unit. The recent evolution of nuclear medicine involves deep consequences in this ever-present regulatory state, and hospital radiopharmacy units cannot be considered as contract manufacturing organizations (CMO). This review provides an updated status report of the official (and non-official) guidelines supporting the regulations required to meet hospital and industry common radiopharmaceutical manufacturing standards to facilitate the current and future innovative radiopharmaceutical development.</p>\",\"PeriodicalId\":73095,\"journal\":{\"name\":\"Frontiers in nuclear medicine (Lausanne, Switzerland)\",\"volume\":\" \",\"pages\":\"990330\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-09-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440975/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in nuclear medicine (Lausanne, Switzerland)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3389/fnume.2022.990330\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in nuclear medicine (Lausanne, Switzerland)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3389/fnume.2022.990330","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
Radiopharmaceutical good practices: Regulation between hospital and industry.
Radiopharmaceutical practices are divided into large-scale industrial manufacturing and small-scale "in-house" hospital radiopharmacy unit. The recent evolution of nuclear medicine involves deep consequences in this ever-present regulatory state, and hospital radiopharmacy units cannot be considered as contract manufacturing organizations (CMO). This review provides an updated status report of the official (and non-official) guidelines supporting the regulations required to meet hospital and industry common radiopharmaceutical manufacturing standards to facilitate the current and future innovative radiopharmaceutical development.
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