HESI 研讨会摘要:发育和生殖毒性终点的解释及对不良事件数据解释的影响

IF 1.6 4区 医学 Q4 DEVELOPMENTAL BIOLOGY Birth Defects Research Pub Date : 2024-02-11 DOI:10.1002/bdr2.2311
M. L. Green, A. Kluever, Connie Chen, S. Dobreniecki, Wendy Halpern, Bethany Hannas, Alan Hoberman, M. E. McNerney, S. Mitchell-Ryan, T. J. Shafer, Steven Van Cruchten, Tacey White
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引用次数: 0

摘要

2022 年,健康与环境科学研究所发育与生殖毒理学(HESI-DART)小组在华盛顿特区举办了一次现场与虚拟混合研讨会。研讨会的主题是 "监管背景和框架下的 DART 解释"。来自 9 个国家的 154 名与会者(37 名亲临现场,117 名虚拟与会者)参加了此次研讨会。研讨会的目的是收集关键的共识方法,用于在发现非临床发现时评估与化学产品暴露相关的 DART 风险。确定 DART 终点是否被视为不利因素的决策过程至关重要,因为其结果可能会产生下游影响(例如,增加动物用量、修改生殖分类和妊娠标签、影响临床试验和价值链的注册)。研讨会包括一系列网络研讨会模块,对联邦和国际监管机构、临床医生、学术研究人员、非政府组织、合同研究组织科学家和私营部门科学家进行培训,并与他们讨论在监管要求和流程背景下解释 DART 和新方法学的最佳实践和原则。尽管化学和制药部门的监管框架不同,但数据解读的基本原则应该相同。通过讨论,对原则进行了分类,为系统解释数据提供了指导。第 1 步需要通过仔细分析研究终点层面的数据来确定任何危害,而第 2 步则涉及使用证据权重来评估风险。这些指导原则源自研讨会的集体讨论结果。
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HESI workshop summary: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse events

The Health and Environmental Sciences Institute Developmental and Reproductive Toxicology (HESI-DART) group held a hybrid in-person and virtual workshop in Washington, DC, in 2022. The workshop was entitled, “Interpretation of DART in Regulatory Contexts and Frameworks.” There were 154 participants (37 in person and 117 virtual) across 9 countries. The purpose of the workshop was to capture key consensus approaches used to assess DART risks associated with chemical product exposure when a nonclinical finding is identified. The decision-making process for determining whether a DART endpoint is considered adverse is critical because the outcome may have downstream implications (e.g., increased animal usage, modifications to reproductive classification and pregnancy labeling, impact on enrollment in clinical trials and value chains). The workshop included a series of webinar modules to train and engage in discussions with federal and international regulators, clinicians, academic investigators, nongovernmental organizations, contract research organization scientists, and private sector scientists on the best practices and principles of interpreting DART and new approach methodologies in the context of regulatory requirements and processes. Despite the differences in regulatory frameworks between the chemical and pharmaceutical sectors, the same foundational principles for data interpretation should be applied. The discussions led to the categorization of principles, which offer guidance for the systematic interpretation of data. Step 1 entails identifying any hazard by closely analyzing the data at the study endpoint level, while Step 2 involves assessing risk using weight of evidence. These guiding principles were derived from the collective outcomes of the workshop deliberations.

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来源期刊
Birth Defects Research
Birth Defects Research Medicine-Embryology
CiteScore
3.60
自引率
9.50%
发文量
153
期刊介绍: The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.
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