Can more data be too much of a good thing for a shelf-life extension? Be careful what you wish for; sometimes more is less in the complicated process of extending shelf life. Read about this situation and please leave your questions and approaches to resolving this stability situation!
The information we have is incomplete. The three later batches that look very good. Are they the result of process improvements that are validated? Is the submitter willing to share the 36 month raw data for review by others?
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