Contents

1. Introduction 2. Accelerated Testing 3. Expiration Dating period 4. Stability Designs 5. Stability Analysis with Fixed Batches 6. Stability Analysis with Random Batches 7. Stability Analysis with a Mixed Effect Model 8. Stability Analysis with Discrete Responses 9. Stability Analysis with Multiple Components 10. Stability Analysis with Frozen Drug Products 11. Stability Testing for Dissolution 12. Current Issues and Recent Developments