This presentation will focus on how to select the appropriate regression model for multiple stability lots to determine or extend expiry per the fixed lot paradigm prescribed in ICH Q1E. The presentation on “ Determining Expiry using Regression” should be viewed before this for ease of understanding.
This video is part of an educational series presented by AAPS. Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients. If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!