Re:The Myth of Drug Expiration Dates
by yomly on Tuesday July 18, 2017 @07:13PM
(#14800785)
I would expect the chemistry to be characterised well enough to the point where you shouldn't need clinical tests to know it's degredation profile...
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| on HN ]
I don't know about that. There are variables beyond theoretical chemistry, like the packaging, the manufacturing process, etc.
I'm not anywhere near knowledgeable on pharma, but I worked on an FDA regulated medical device. If we made a claim, we had to test it. Knowing that e.g. every component in the machine was rated safe between temperatures X and Y did not mean that we didn't have to perform real environmental testing.
Regulations don't want you to rely on models.