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R包的开发:用于非房室分析(NCA)的“”和“” 。 (注:原文中两个引号处内容缺失)

Development of R packages: '' and '' for noncompartmental analysis (NCA).

作者信息

Kim Hyungsub, Han Sungpil, Cho Yong-Soon, Yoon Seok-Kyu, Bae Kyun-Seop

机构信息

Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan, Seoul 05505, Republic of Korea.

出版信息

Transl Clin Pharmacol. 2018 Mar;26(1):10-15. doi: 10.12793/tcp.2018.26.1.10. Epub 2018 Mar 16.

Abstract

Noncompartmental analysis (NCA) is a primary analytical approach for pharmacokinetic studies, and its parameters act as decision criteria in bioequivalent studies. Currently, NCA is usually carried out by commercial softwares such as WinNonlin®. In this article, we introduce our newly-developed two R packages, (NonCompartmental analysis for pharmacokinetic data) and (NonCompartmental Analysis for pharmacokinetic Report), which can perform NCA and produce complete NCA reports in both pdf and rtf formats. These packages are compatible with CDISC (Clinical Data Interchange Standards Consortium) standard as well. We demonstrate how the results of WinNonlin® are reproduced and how NCA reports can be obtained. With these R packages, we aimed to help researchers carry out NCA and utilize the output for early stages of drug development process. These R packages are freely available for download from the CRAN repository.

摘要

非房室分析(NCA)是药代动力学研究的主要分析方法,其参数在生物等效性研究中作为决策标准。目前,NCA通常由WinNonlin®等商业软件进行。在本文中,我们介绍了我们新开发的两个R包,(药代动力学数据的非房室分析)和(药代动力学报告的非房室分析),它们可以执行NCA并生成pdf和rtf格式的完整NCA报告。这些包也与CDISC(临床数据交换标准协会)标准兼容。我们展示了如何重现WinNonlin®的结果以及如何获得NCA报告。通过这些R包,我们旨在帮助研究人员进行NCA并将输出结果用于药物开发过程的早期阶段。这些R包可从CRAN存储库免费下载。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d662/6989226/ce9033af3832/tcp-26-10-g001.jpg

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