{"title":"药物警戒原则:利益-风险评估的基石","authors":"Rosa Piccirillo, Jennifer Parish","doi":"10.36316/gcatr.04.0045","DOIUrl":null,"url":null,"abstract":"A medicinal product must demonstrate a favorable benefit-risk balance to remain on the market. That the benefits of use outweigh the risks is established using analyses referred to as benefit-risk assessments, which are conducted on an ongoing basis throughout the lifecycle of a medicinal product. While fundamental to maintaining a product’s marketing authorization, few regulatory guidance documents have been developed to provide information on the specific content and structure of a benefit-risk assessment. This paper aims to provide an overview of the key concepts in pharmacovigilance that contribute to the creation of a structured benefit-risk assessment, particularly through qualitative analysis.","PeriodicalId":265939,"journal":{"name":"Global Clinical and Translational Research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Pharmacovigilance Principles: The Building Blocks of Benefit-Risk Assessments\",\"authors\":\"Rosa Piccirillo, Jennifer Parish\",\"doi\":\"10.36316/gcatr.04.0045\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A medicinal product must demonstrate a favorable benefit-risk balance to remain on the market. That the benefits of use outweigh the risks is established using analyses referred to as benefit-risk assessments, which are conducted on an ongoing basis throughout the lifecycle of a medicinal product. While fundamental to maintaining a product’s marketing authorization, few regulatory guidance documents have been developed to provide information on the specific content and structure of a benefit-risk assessment. This paper aims to provide an overview of the key concepts in pharmacovigilance that contribute to the creation of a structured benefit-risk assessment, particularly through qualitative analysis.\",\"PeriodicalId\":265939,\"journal\":{\"name\":\"Global Clinical and Translational Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-11-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Global Clinical and Translational Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.36316/gcatr.04.0045\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Global Clinical and Translational Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.36316/gcatr.04.0045","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Pharmacovigilance Principles: The Building Blocks of Benefit-Risk Assessments
A medicinal product must demonstrate a favorable benefit-risk balance to remain on the market. That the benefits of use outweigh the risks is established using analyses referred to as benefit-risk assessments, which are conducted on an ongoing basis throughout the lifecycle of a medicinal product. While fundamental to maintaining a product’s marketing authorization, few regulatory guidance documents have been developed to provide information on the specific content and structure of a benefit-risk assessment. This paper aims to provide an overview of the key concepts in pharmacovigilance that contribute to the creation of a structured benefit-risk assessment, particularly through qualitative analysis.