经济短缺
模式
业务
大流行
风险分析(工程)
2019年冠状病毒病(COVID-19)
食品药品监督管理局
医学
药物开发
资源(消歧)
药品
药理学
计算机科学
传染病(医学专业)
计算机网络
社会科学
语言学
哲学
疾病
病理
政府(语言学)
社会学
作者
David H. Ackley,Joanne Birkebak,Jörg Blümel,Todd Bourcier,Christina de Zafra,Andrew L. Goodwin,Wendy Halpern,Danuta J. Herzyk,Sven Kronenberg,Robert J. Mauthe,Jacintha Shenton,Dana Shuey,Ronald L. Wange
标识
DOI:10.1016/j.yrtph.2022.105327
摘要
The nonhuman primate (NHP) has always been a limited resource for pharmaceutical research with ongoing efforts to conserve. This is due to their inherent biological properties, the growth in biotherapeutics and other modalities, and their use in small molecule drug development. The SARS-CoV-2 pandemic has significantly impacted the availability of NHPs due to the immediate need for NHPs to develop COVID-19 vaccines and treatments and the China NHP export ban; thus, accelerating the need to further replace, reduce and refine (3Rs) NHP use. The impact of the NHP shortage on drug development led DruSafe, BioSafe, and the United States (U.S.) Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) to discuss this issue at their 2021 annual meeting. This meeting identified areas to further the 3Rs in NHP use within the current nonclinical safety evaluation regulatory framework and highlighted the need to continue advancing alternative methods towards the aspirational goal to replace use of NHPs in the long term. Alignment across global health authorities is necessary for implementation of approaches that fall outside existing guidelines. This article captures the proceedings from this meeting highlighting current best practices and areas for 3Rs in NHP use.
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