撰写模型和模拟分析报告:我们在药物计量学领域的经验

Q2 Health Professions

Medical Writing Pub Date : 2023-09-22 DOI:10.56012/wmqy8556

Viviana Moroso, Mats Magnusson, E. Niclas Jonsson

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引用次数: 0

摘要

药物计量学分析产生数学模型，可以描述和模拟药物的药代动力学和药效学。这些建模和模拟(M&S)分析在药物开发和监管评估中的作用越来越大。由于需要在监管报告中总结和准确描述大量输入和输出数据，报告M&S分析在技术上可能具有挑战性。因此，再现性、自动化、可追溯性和标准化被认为是这个过程的关键方面。我们在这里提出一个系统，使用软件组合，满足这些挑战，提高效率，准确性和可靠性我们的工作。

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Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work.

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来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.