Bristol Myers Squibb, PO Box 4000, Princeton, New Jersey, 08543-4000, USA.
AAPS J. 2024 Apr 3;26(3):39. doi: 10.1208/s12248-024-00910-0.
A well-documented pharmacometric (PMx) analysis dataset specification ensures consistency in derivations of the variables, naming conventions, traceability to the source data, and reproducibility of the analysis dataset. Lack of standards in creating the dataset specification can lead to poor quality analysis datasets, negatively impacting the quality of the PMx analysis. Standardization of the dataset specification within an individual organization helps address some of these inconsistencies. The recent introduction of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model (ADaM) Population Pharmacokinetic (popPK) Implementation Guide (IG) further promotes industry-wide standards by providing guidelines for the basic data structure of popPK analysis datasets. However, manual implementation of the standards can be labor intensive and error-prone. Hence, there is still a need to automate the implementation of these standards. In this paper, we present PmWebSpec, an easily deployable web-based application to facilitate the creation and management of CDISC-compliant PMx analysis dataset specifications. We describe the application of this tool through examples and highlight its key features including pre-populated dataset specifications, built-in checks to enforce standards, and generation of an electronic Common Technical Document (eCTD)-compliant data definition file. The application increases efficiency, quality and semi-automates PMx analysis dataset, and specification creation and has been well accepted by pharmacometricians and programmers internally. The success of this application suggests its potential for broader usage across the PMx community.
一份有充分文件记录的药物计量学（PMx）分析数据集规范可确保变量的推导、命名约定、与源数据的可追溯性以及分析数据集的可重复性保持一致。在创建数据集规范时缺乏标准可能会导致分析数据集质量较差，从而对 PMx 分析的质量产生负面影响。在单个组织内规范数据集规范的标准化有助于解决其中的一些不一致性。最近临床数据交换标准协会（CDISC）分析数据模型（ADaM）群体药代动力学（popPK）实施指南（IG）的引入通过为 popPK 分析数据集的基本数据结构提供指南，进一步推动了行业范围内的标准。然而，手动实施这些标准可能既费力又容易出错。因此，仍然需要自动化这些标准的实现。在本文中，我们介绍了 PmWebSpec，这是一个易于部署的基于网络的应用程序，用于方便创建和管理符合 CDISC 的 PMx 分析数据集规范。我们通过示例描述了该工具的应用，并强调了其关键功能，包括预填充的数据集规范、内置检查以强制执行标准以及生成符合电子通用技术文档（eCTD）的数据定义文件。该应用程序提高了效率、质量，并实现了 PMx 分析数据集和规范的半自动创建，并且受到内部药物计量学家和程序员的广泛认可。该应用程序的成功表明了其在 PMx 社区更广泛使用的潜力。
