This free recorded course covers stability analysis across product phases. The demonstrations were recorded in an older version of JMP, but the concepts and principles for assessing product stability remain the same. The methods shown in this course can be used in your current version of JMP, although in some cases the menu steps might have changed.
- Lesson 1 defines product stability, explains the purpose of stability testing, and discusses the need for evaluating stability data in each product phase.
- Lesson 2 demonstrates evaluation during the pre-clinical phase, including validating storage conditions, and using data from accelerated studies.
- Lesson 3 covers appropriate techniques for analyzing clinical lots, testing poolability, and determining expiry.
- Lesson 4 shows analysis of stability data for commercial batches, and discusses methods for identifying out-of-specification and out-of-trend results.
Download the course file (stability-analysis-journal.zip) at the top of the page to use in the course.