EN
PL
We continue our exploration of the proposed changes to the ICH Q1 guidelines on stability studies! Following the strong interest in the first webinar, we are pleased to invite you to the second part of the series—this time focusing on statistical methods for evaluating stability data from multiple batches using mixed-effects models.
The first session covered statistical approaches for assessing stability data from a single batch as well as multiple batches for a single factor, based on analysis of covariance (ANCOVA) and fixed-effects models. These topics were also further elaborated in an article by our expert, Marek Skowronek: Statistical methods as per draft of ICH Q1 – Part 1
In the second webinar, we will take things a step further.
What will we focus on?
We will discuss mixed-effects models in the analysis of stability data from multiple batches. This approach allows for a more flexible and realistic representation of between-batch variability and better reflects the structure of the data—an aspect that is particularly important in light of the proposed updates to the ICH Q1 guidelines.
Practical session
During the webinar, we will also present the StatSoft PS application, which supports the preparation of statistical reports for stability data evaluation.
Why should you attend?
• Learn a modern approach to stability data analysis
• Understand how the proposed changes to ICH Q1 may impact your work
• See practical applications of statistical methods in a dedicated tool
We encourage you to join us. See you at the webinar!
- Registration for the webinar in Polish: Propozycja zmian w wytycznych ICH Q1, dotyczących badań stabilności. Część 2.
- Registration for the webinar in English: Proposed changes to ICH Q1 guidelines on stability testing. Part 2.