研究完整性和监督办公室对生物利用率/生物等效性研究行为的远程监管评估。

IF 3.4 4区医学 Q2 PHARMACOLOGY & PHARMACY AAPS PharmSciTech Pub Date : 2024-10-10 DOI:10.1208/s12249-024-02967-8

Monica Javidnia, Hasan A. Irier, Sean Kassim, Seongeun Julia Cho

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引用次数: 0

摘要

美国食品及药物管理局 CDER 研究完整性和监督办公室 (OSIS) 负责协调和开展对开展生物可用性和/或生物等效性 (BA/BE) 研究的研究机构的检查，以支持提交监管申请。为应对 SARS-CoV-2 (COVID-19) 公共卫生紧急事件期间的旅行限制，OSIS 制定并于 2020 年开始对 BA/BE 研究机构进行远程评估。本文概述了远程监管评估 (RRA) 和 OSIS 的 RRA 方法，包括程序、经验和 RRA 期间发现的实例。此外，随着 OSIS 继续利用 RRA 恢复检查，本文还讨论了一些需要改进的领域。

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Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance

The Office of Study Integrity and Surveillance (OSIS) in CDER in FDA coordinates and conducts inspections of sites conducting bioavailability and/or bioequivalence (BA/BE) studies supporting regulatory submissions. In response to travel restrictions during the SARS-CoV-2 (COVID-19) public health emergency, OSIS developed and began conducting remote assessments of BA/BE sites in 2020. This paper provides an overview of remote regulatory assessments (RRAs) and OSIS’s approach to RRAs, including procedures, experiences, and examples of findings during RRAs. In addition, as OSIS continues to utilize RRAs while resuming inspections, some areas for improvement are discussed.

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来源期刊

AAPS PharmSciTech 医学-药学

CiteScore

6.80

自引率

3.00%

发文量

264

审稿时长

2.4 months

期刊介绍： AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.