Combistats是一款生物稀释测定了局或效价测定了局的统计分析在线利用法式。

该利用法式由欧洲药品质量治理局（EDQM）开发
，可凭据《欧洲药典》第5.3章进行推算。蕴含以下模型：

• 定量了局的线性回归模型：平行线分析和斜率比分析模型

• 定量了局的S形曲线模型：4参数和5参数逻辑回归模型

• 定性（通过/失败）了局的4参数逻辑回归模型：支持多种数据转换（如概率单元、对数单元）及有效剂量推算

• 单剂量测定分析：选取Wilcoxon-Mann-Whitney检验

?

CombiStats专为从事测定数据分析但未接受过系十足计学培训的人员设计。文档中提供了有关统计分析的重要重点作为支持。

该利用法式合用于所有必要分析稀释测定数据的场景
，蕴含《欧洲药典》各论项下的利用。

CombiStats：新版亮点

CombiStats是凭据《欧洲药典》第5.3章进行生物测定和试验了局统计分析的专用推算法式。该网络利用法式于2024年7月4日颁布。这一全新版本提供以下职能：

??

1. 矫捷的许可证治理系统
用户通过EDQM商店注册后
，将收到对应的许可证密钥（CSID）及申请的用户接见数量。担任许可证治理员的用户可为同事分配权限？突Ф丝芍笔帐芾淼骰
，例如：移交治理员角色、撤销用户权限或沉新分配接见权限。许可证密钥续期可通过EDQM商店申请。

?

2. 专属工作区
启用许可证密钥后将创建专属工作区
，用户可通过登录名和密码接见。用户可自界说文件夹树结构
，与工作区其他用户或特定前提下与表部用户共享文件夹。CombiStats天生的文件支持沉起名、移动、；ぁ⑸境氨镜氐汲觯ú⒖汕崴沙列碌既耄。值妥贴心的是
，使用CombiStats桌面版5.0到7.0创建的文件可导入该网络利用法式持续处置。

?

3. 现代化用户界面
用户可在分歧面板间切换以实现数据录入、向导与高 级分析选项选择、回归分析图表查看或审计追踪内容查阅。部门回归分析了局和分析汇报可别离导出为Excel表格和PDF文档。

利用法式内置大量即时提醒信息疏导用户使用
，同时提供援手页面链接到针对分歧职能的利用注明。

?

4. 丰硕的统计模型与选项

• 定量了局分析：可选取线性平行线分析、斜率比分析或S形曲线模型（4参数和5参数逻辑模型）

• 定性了局分析：4参数逻辑模型支持概率单元（Probits）和对数单元（Logits）等多种转换

• 单剂量测定分析：选取限度检验

?

?

对于平行线测定
，CombiStats可创建数据子集（剂量与了局）并汇报典型有效性尺度值（如非线性、非平行性p值）。法式会尽可能保留更多剂量
，并显示切合有效性要求且拥咏ī陡斜率（或蕞高R?）子集的统计了局。

?

测定布局可展示尝试流程（随机、区组或拉丁方设计）？ 白了局可在独立表格中输入
，并通过单一统计量（均值、尺度差和变异系数）进行汇总。

?

蕞后
，法式支持归并屡次测定的效价了局。CombiStats凭据第5.3章描述的三种推算步骤
，汇报均匀效价值及其相信限。

?

【英文介绍】

Online application for the Statistical Analysis of Biological Dilution Assay Results or Potency Assay Results

?

The application was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia. The following models are included:

?

Linear regression models for quantitative results: parallel line and slope ratio analysis models,

Sigmoid models for quantitative results: 4- and 5-parameter logistic regression models,

4-parameter logistic regression model for quantal (pass/fail) results, including several data transformations (e.g. probit, logit) and effective doses calculation,

Analysis of single-dose assays using the Wilcoxon-Mann-Whitney test.

?

CombiStats is intended for use by persons who perform the analysis of assay data but whose primary training is not in statistics. In support, the main statistical aspects of such analysis are available in the documentation.

?

The application may be used in any situation where the analysis of data from dilution assays is required including for use in the context of monographs of the European Pharmacopoeia.

?

CombiStats: What's new??

?

CombiStats is the calculation program for the statistical analysis of results of biological assays and tests, according to Chapter 5.3 of the European Pharmacopoeia. The web-application was released on 4 July 2024. This brand-new version of the software offers a:

?

1、Flexible license management system

Upon registration using the EDQM Store, a unique licence key (CSID) together with the number of user access requested is sent to the client. The user who takes the role of licence manager can then assigns colleagues. Changes are managed at the client level directly, e.g., the role of licence manager can be passed on another user, users can be revoked and their access assigned to others. The renewal of the licence key can be requested using the EDQM Store.

?

2、Dedicated workspace

The licence key activation results in the creation of a dedicated workspace accessible to users using their login and password. Users can create their own folder tree and share folders with users of the workspace and even with external users, under certain conditions. Created CombiStats files can be renamed, moved, protected, deleted and exported locally (and reimported easily). Importantly, the files created using the CombiStats Desktop versions 5.0 to 7.0 can be imported and processed in the web application.

?

3、Modern user-interface

The user can navigate between various panels in order to enter data, select Wizard and advanced analysis options, visualise regression analysis plots, or consult the content of the audit trail. Some regression analysis results and the final analysis report can be exported locally as an Excel table and PDF document, respectively.

?

The application comes with many information instant messages to guide the user through the application. A Help page is also available with links to several notes addressing different aspects of the application.

?

4、Large set of statistical models and options

Quantitative results can be analysed using linear parallel line or slope ratio analyses or sigmoid curve models (4- and 5-parameter logistic models). The 4-parameter logistic model used for quantal responses (e.g. pass/fail results) comes with several transformations including Probits and Logits. Single-dose assays are analysed using a limit test.

?

For the parallel line assay, CombiStats can create subsets of data (doses and results) and report the values of typical validity criteria (e.g. non-linearity, non-parallelism p-values). CombiStats keeps as many doses as possible and display the statistical results of a valid subset that shows the steepest slope (or highest R?).

?

The assay layout can be displayed to specify of the course of the experiments (at random, by blocks, or as a Latin square design). Blank results can be entered in a separate table and summarised using simple statistics (mean, standard deviation, and coefficient of variation).

?

Last but not least, the potency results of several assays can be combined. CombiStats reports the averaged potency values and confidence limits for the 3 calculation approaches described in Chapter 5.3.