Cosmetic safety assessment has distinct characteristics of interdisciplinary and extensive intersection,intensive technical knowledge,and high professional requirements.China is confronted with problems such as a lack...Cosmetic safety assessment has distinct characteristics of interdisciplinary and extensive intersection,intensive technical knowledge,and high professional requirements.China is confronted with problems such as a lack of professional safety assessment personnel and review personnel for cosmetic safety assessment.The compliance of safety assessment reports has become one of the important factors affecting the process of cosmetic filing and listing.This article contains the comprehensive analysis on the requirements of relevant regulations and technical documents for cosmetic safety assessment,as well as the judgment principles,and specific requirements of safety assessment reports.The key issues in current cosmetic safety assessment and the safety assessment requirements for typical products also are being focused on,so as to help standardize and unify the review standards of cosmetic safety assessment report,and provide reference for cosmetic filers.展开更多
结局测量工具(OMI)是评估患者感受或健康状况的重要工具,但其质量参差不齐。选择健康测量工具的共识标准(COSMIN)为遴选高质量的OMI提供了方法学指导,得到广泛认可。近年来,基于COSMIN开展的OMI系统评价数量激增,然而许多已发表的相关...结局测量工具(OMI)是评估患者感受或健康状况的重要工具,但其质量参差不齐。选择健康测量工具的共识标准(COSMIN)为遴选高质量的OMI提供了方法学指导,得到广泛认可。近年来,基于COSMIN开展的OMI系统评价数量激增,然而许多已发表的相关系统评价常未能充分报告关键信息,严重影响了OMI系统评价的可重复性和可解释性,从而影响其结果的推广应用。鉴于PRISMA 2020未包含报告此类系统评价的所有必要信息,有关学者在前者基础上制订了新的报告规范“PRISMA-COSMIN for OMIs 2024”,以帮助研究人员以清晰、详细和透明的方式撰写和报告OMI系统评价。本文结合实例对该规范进行了介绍和解读,旨在帮助国内学者深入理解并有效应用该指南,提高国内OMI系统评价进行全面地的整体质量。展开更多
文摘Cosmetic safety assessment has distinct characteristics of interdisciplinary and extensive intersection,intensive technical knowledge,and high professional requirements.China is confronted with problems such as a lack of professional safety assessment personnel and review personnel for cosmetic safety assessment.The compliance of safety assessment reports has become one of the important factors affecting the process of cosmetic filing and listing.This article contains the comprehensive analysis on the requirements of relevant regulations and technical documents for cosmetic safety assessment,as well as the judgment principles,and specific requirements of safety assessment reports.The key issues in current cosmetic safety assessment and the safety assessment requirements for typical products also are being focused on,so as to help standardize and unify the review standards of cosmetic safety assessment report,and provide reference for cosmetic filers.
文摘结局测量工具(OMI)是评估患者感受或健康状况的重要工具,但其质量参差不齐。选择健康测量工具的共识标准(COSMIN)为遴选高质量的OMI提供了方法学指导,得到广泛认可。近年来,基于COSMIN开展的OMI系统评价数量激增,然而许多已发表的相关系统评价常未能充分报告关键信息,严重影响了OMI系统评价的可重复性和可解释性,从而影响其结果的推广应用。鉴于PRISMA 2020未包含报告此类系统评价的所有必要信息,有关学者在前者基础上制订了新的报告规范“PRISMA-COSMIN for OMIs 2024”,以帮助研究人员以清晰、详细和透明的方式撰写和报告OMI系统评价。本文结合实例对该规范进行了介绍和解读,旨在帮助国内学者深入理解并有效应用该指南,提高国内OMI系统评价进行全面地的整体质量。
