{"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":null,"pages":null},"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}
引用次数: 0
Abstract
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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