Stability analysis, expiration time and poolability. If you are part of an organization that is launching a new pharmaceutical, these are all high-priority topics. How long will your product perform at its intended potency, and under what conditions? Is your batch-to-batch variability small enough that data from different batches can be combined for an overall estimate of a single shelf life? Join Byron Wingerd as he walks you through the regulatory requirements for these analyses — specifically, ICH Q1E — and demonstrates how modern statistical software simplifies the process of compliance.
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 test variability across batches.
- How built-in features in JMP® software specifically designed for stability testing simplify regulatory compliance.