Stability Analysis Made Easier
For many, determining a shelf life for drug products in accordance with FDA guidelines can be a time-consuming and uncertain process. Watch this 20-minute webinar to learn how JMP® software from SAS — designed specifically to guide you through FDA-prescribed stability testing requirements — can make your life easier.
JMP offers built-in stability testing capabilities designed to simplify the determination of expiration times in accordance with ICH guidelines.
Join Byron Wingerd as he walks you through the regulatory requirements for stability testing and demonstrates how modern statistical software can simplify the process of compliance.
In roughly 20 minutes, you will learn about:
- Confidence interval requirements: what they mean and how to calculate them.
- How to apply linear degradation models in accordance with ICH guidelines to estimate expiration dates.
- How an analysis of covariance (ANCOVA) model can be employed to determine poolability of data from different batches.
- How built-in features in JMP® software specifically designed for stability testing simplify regulatory compliance.
- Additional opportunities to learn more about how to integrate the techniques outlined in FDA regulations and ICH guidelines into your stability program.