综合安全评价计划的价值与实施。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2023-05-01 DOI:10.1007/s40290-023-00470-2
Barbara A Hendrickson, Anupam Agarwal, Dimitri Bennett, Jürgen Kübler, Cynthia McShea, Lothar Tremmel
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引用次数: 0

摘要

综合安全评估包括对安全数据的总体评估,以表征产品的新安全概况。药物信息协会-美国统计协会跨学科安全评估科学工作组最近发布了一项制定综合安全评估计划(ASAP)的方法。ASAP的创建有助于在研究中收集和分析安全数据的一致方法,并最大限度地减少提交监管时的重要丢失数据。ASAP的一个关键方面是确定安全利益主题(STOI)。根据ASAP的定义,STOI包括不良事件(ae),这些不良事件有可能影响产品的收益:风险概况,通常需要专门的数据收集或分析。虽然为药物开发项目制定ASAP有明显的好处,但在实施过程中可能会遇到多种问题。本文使用两个stoi的示例来演示在安全规划中实施ASAP所获得的好处和效率,以及在最佳地描述产品的新安全概况方面。
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Value and Implementation of the Aggregate Safety Assessment Plan.

Aggregate safety assessment involves evaluation of the totality of safety data to characterize the emerging safety profile of a product. The Drug Information Association-American Statistical Association Interdisciplinary Safety Evaluation scientific working group recently published an approach to developing an Aggregate Safety Assessment Plan (ASAP). Creation of an ASAP facilitates a consistent approach to safety data collection and analysis across studies and minimizes important missing data at the time of regulatory submission. A critical aspect of the ASAP is identification of the Safety Topics of Interest (STOI). The STOI, as defined in the ASAP, comprises adverse events (AEs), which have the potential to impact the benefit: risk profile of a product and typically require specialized data collection or analyses. While there are clear benefits to developing an ASAP for a drug development program, multiple concerns may be encountered with implementation. This article uses the examples of two STOIs to demonstrate the benefits and efficiencies gained with implementation of the ASAP in safety planning as well as in optimally characterizing the emerging safety profile of a product.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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