Home Forums General Discussion How to apply ICH Q1E shelf life extrapolation before 6m timepoint Reply To: How to apply ICH Q1E shelf life extrapolation before 6m timepoint

John O’Neill
Moderator
Post count: 33

Hello Snicket,
While the timing of this response is well past your immediate need, a question that popped up at a Stability Statistics seminar yesterday, put me in mind of your topic. When you are not yet to the first Q1E waypoint, it is not unusual to obtain permission to enter a clinical investigation with 3 months of satisfactory data for a provisional 6 month expiry and a promise that 6 months will be obtained. If there is not a lot of data to be confident in the 6 month result, then other monthly points can be inserted to build confidence. Depending on your region, a lot of re-labeling for a changing shelf-life could be involved. As always, you are a team of Stability, Quality Assurance and Regulatory. Be sure that you assemble a solid justification, document your decision and approval and then start working with the authorities. Further comment by StabilityHub subscribers are welcome.
Best regards,
John O’Neill