JMP^®: Stability Analysis

Learn how to:

• Interpret FDA regulations and ICH guidelines concerning stability evaluation
• Apply those techniques to your stability program
• Choose techniques that are best for your program.

Before attending this course, you should:

• Complete the JMP® Software: A Case Study Approach to Data Exploration course or have equivalent experience
• Complete the JMP®: Statistical Decisions Using ANOVA and Regression course or have equivalent experience
• Have some knowledge of the basic tenets of stability testing for drug substances or products.

FDA Regulations, ICH Guidances, and Guidance Documents from the PhRMA CMC Statistics Group

• Review Stabilty Expert Team findings for definition of stability and scope of studies
• Relate requirements in 21 CFR parts to stability assessment and determination of expiry
• Use ICH guidance Q1A (R2) Stability Testing and New Drug Substances and Products
• Use ICH guidance Q1E Evaluation of Stability Data

Stability Studies Based on the Product Life Cycle

• Present a framework for the progression of stability studies
• Identify necessary stability studies for submissions for pre-clinical, clinical, and commercial batches of drug substances and products

Estimate Expiry from Accelerated Degradation Tests

• Learn to select and fit a degradation model
• Learn to extrapolate to long-term storage conditions

Determining Poolability and Verifying Expiry of Clinical and Commercial Batches

• Learn to use recommended methods
• Perform simple linear regression and inverse prediction
• Perform analysis of covariance (ANCOVA)
• Confidence, prediction, and tolerance intervals

Determining Out-of-Specification Batches and Alerts for Out-of-Trend Batches

• Learn to use recommended methods such as by time point method, slope control chart method, and regression control chart method