Evolution of the Stabilis® Database: Creation of a Level of Evidence for Stability Studies

E. D’huart, P. Lider, J. Vigneron, B. Demoré
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引用次数: 3

Abstract

Abstract Background Stabilis® is an international database on stability and compatibility of drugs. The stability data comes mainly from publications of pharmaceutical journals. As the quality of the published stability studies is not equivalent, the objective of this work was to propose a level of evidence for the physico-chemical stability studies selected for the database. Methods At first, we evaluated the main pharmacological class consulted by the users. This work was then divided into 5 steps: (1) updating of the criteria to validate a stability study, (2) creating a grid rating articles, (3) rating of the articles of stability studies for anticancer, antifungal and antiviral drugs by 2 evaluators, (4) creation of new screens in the database to enter rating, to visualize the pictograms and commentaries by the users, (5) creation of a guideline to explain the different levels of evidence. Results The main pharmacological class consulted by Stabilis® users is the anticancer drugs and then antiinfectives. We have selected anticancer, antifungal and antiviral drugs for our study. Two hundred and forty publications were evaluated. The highest level attributed was A for anticancer and antifungal drugs and C for antiviral drugs. This difference can be explained by the fact that the majority of publications about antiviral drugs were older. The most frequent anomalies in the rating of articles were an incomplete or imperfect validation of the analytical method (high value of the coefficient of variation) and a defect in the evaluation of the stability indicating capacity. It must be noted that the level of evidence is not the quality level of the analytical method but the mixture of the quality of the method validation and of the results. This aspect was a choice of the Stabilis® team and seems important because the security of the patient is impacted by both aspects. Conclusions This new function contributes to help the Stabilis® users to evaluate the stability data published and to take a decision for their use in daily practice. This function will be progressively extended to other pharmacological classes of injectable drugs and then for non-injectable preparations.
Stabilis®数据库的发展:为稳定性研究提供证据
Stabilis®是一个关于药物稳定性和相容性的国际数据库。稳定性数据主要来源于药学期刊的出版物。由于已发表的稳定性研究的质量不相等,本工作的目的是为数据库选择的物理化学稳定性研究提出一个证据水平。方法首先对用户咨询的主要药理学类进行评价。这项工作随后分为5个步骤:(1)更新标准以验证稳定性研究,(2)创建网格评级文章,(3)由2名评估人员对抗癌、抗真菌和抗病毒药物的稳定性研究文章进行评级,(4)在数据库中创建新的屏幕以输入评级,可视化用户的象形图和评论,(5)创建指南以解释不同水平的证据。结果安定者咨询的药理学类别以抗癌药为主,其次为抗感染药。我们选择了抗癌、抗真菌和抗病毒药物进行研究。评估了240份出版物。最高水平为抗癌和抗真菌药物A和抗病毒药物C。这种差异可以解释为大多数关于抗病毒药物的出版物都较旧。文章评级中最常见的异常是分析方法的不完整或不完美验证(变异系数的高值)和稳定性评估中的缺陷。必须注意的是,证据水平不是分析方法的质量水平,而是方法验证质量和结果质量的混合。这方面是Stabilis®团队的选择,似乎很重要,因为患者的安全受到这两个方面的影响。这个新功能有助于帮助Stabilis®用户评估发布的稳定性数据,并在日常实践中做出使用决定。这一功能将逐步扩展到其他药理学类别的可注射药物,然后用于非可注射制剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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