Live Webinar

JMP on Tuesday

Assessing Comparability in Post-Approval Changes: Utilizing Mixed Model ANOVA for Stability Data Analysis

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Date: 14 May, Tuesday
Time: 1 - 1:45 p.m. (Malaysia & Singapore) | 10:30 - 11:15 a.m. (India) | 3 - 3:45 p.m. (Australia)
Presenter: Rakesh Goud Vasker
Location: Zoom Live Webinar
Registration: Free for JMP users and non-users

Improving manufacturing processes is crucial for business continuity, especially after regulatory approval. Manufacturers must ensure that product quality remains consistent before and after making changes (ICH Q5E, 2005). This consistency is often shown by setting comparability acceptance criteria using various statistical methods on data from batches before the changes.

A key part of proving product consistency involves assessing stability before and after changes. The mixed model ANOVA analysis is a significant statistical method used for this assessment as it analyzes stability data from pre- and post-batch changes. This technique allows for the modeling of continuous responses and considers random factors, optional fixed factors, and covariates for thorough analysis.

Join us in this webinar to learn more about: 

  • Comparability assessment of stability data 
  • Mixed model ANOVA
  • Random effects
  • Fixed effects
  • A case study using JMP    
  • Analysis interpretation and result

Recommended level: Beginner to intermediate

Register now to attend online.

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