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This is a normal physiological process
There are only two reasons to stop a clinical trial in the middle, Bob Seevers, a former FDA reviewer, now a regulatory consultant, tells Outside Run
For context, the underlying lyophilized peptide can remain stable for one to two years or longer when stored correctly before reconstitution, making the post-reconstitution window the most critical and time-limited phase of the entire storage cycle
Meshi D, Drew MR, Saxe M, Ansorge MS, David D, Santarelli L, et al
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