{"title":"生物活性物质的安全性和有效性评估是否成熟?","authors":"Johanna T. Dwyer","doi":"10.1016/j.mam.2022.101103","DOIUrl":null,"url":null,"abstract":"<div><p>This article describes why the safety and efficacy assessment of non-nutrient bioactives for reducing chronic disease risk is so complicated, especially for dietary supplements and traditional medicines. Scientists, regulators, and the public have different and sometimes opposing perspectives about bioactives. Drug, food, and traditional medicine models used for bioactive safety assessment are based on different assumptions and use different processes. Efficacy assessment is seldom based on clinical trials of boactives’ effects in reducing chronic disease risk. It usually consists of application of quality assurance measures and evaluation of label claims and commercial speech about ingredients or products to ensure conformity to regulations. Harmonization of safety and efficacy assessment on a global basis is difficult because of differences within and between regulatory systems. The recommendations provided may open the way for bioactives to play a larger health role in the future, fill gaps in data needed for crafting authoritative dietary guidance on intakes, and speed harmonization of global standards.</p></div>","PeriodicalId":49798,"journal":{"name":"Molecular Aspects of Medicine","volume":null,"pages":null},"PeriodicalIF":8.7000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9841065/pdf/","citationCount":"4","resultStr":"{\"title\":\"Have safety and efficacy assessments of bioactives come of age?\",\"authors\":\"Johanna T. Dwyer\",\"doi\":\"10.1016/j.mam.2022.101103\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>This article describes why the safety and efficacy assessment of non-nutrient bioactives for reducing chronic disease risk is so complicated, especially for dietary supplements and traditional medicines. Scientists, regulators, and the public have different and sometimes opposing perspectives about bioactives. Drug, food, and traditional medicine models used for bioactive safety assessment are based on different assumptions and use different processes. Efficacy assessment is seldom based on clinical trials of boactives’ effects in reducing chronic disease risk. It usually consists of application of quality assurance measures and evaluation of label claims and commercial speech about ingredients or products to ensure conformity to regulations. Harmonization of safety and efficacy assessment on a global basis is difficult because of differences within and between regulatory systems. The recommendations provided may open the way for bioactives to play a larger health role in the future, fill gaps in data needed for crafting authoritative dietary guidance on intakes, and speed harmonization of global standards.</p></div>\",\"PeriodicalId\":49798,\"journal\":{\"name\":\"Molecular Aspects of Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.7000,\"publicationDate\":\"2023-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9841065/pdf/\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Molecular Aspects of Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0098299722000486\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Molecular Aspects of Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0098299722000486","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
Have safety and efficacy assessments of bioactives come of age?
This article describes why the safety and efficacy assessment of non-nutrient bioactives for reducing chronic disease risk is so complicated, especially for dietary supplements and traditional medicines. Scientists, regulators, and the public have different and sometimes opposing perspectives about bioactives. Drug, food, and traditional medicine models used for bioactive safety assessment are based on different assumptions and use different processes. Efficacy assessment is seldom based on clinical trials of boactives’ effects in reducing chronic disease risk. It usually consists of application of quality assurance measures and evaluation of label claims and commercial speech about ingredients or products to ensure conformity to regulations. Harmonization of safety and efficacy assessment on a global basis is difficult because of differences within and between regulatory systems. The recommendations provided may open the way for bioactives to play a larger health role in the future, fill gaps in data needed for crafting authoritative dietary guidance on intakes, and speed harmonization of global standards.
期刊介绍:
Molecular Aspects of Medicine is a review journal that serves as an official publication of the International Union of Biochemistry and Molecular Biology. It caters to physicians and biomedical scientists and aims to bridge the gap between these two fields. The journal encourages practicing clinical scientists to contribute by providing extended reviews on the molecular aspects of a specific medical field. These articles are written in a way that appeals to both doctors who may struggle with basic science and basic scientists who may have limited awareness of clinical practice issues. The journal covers a wide range of medical topics to showcase the molecular insights gained from basic science and highlight the challenging problems that medicine presents to the scientific community.