How do you get this data for a large value of X without having to wait X years?
How do you get this data for a large value of X without having to wait X years?
Though in practice it’s more complicated. Basically, make predictions based on accelerated testing and then validate them in real time tests. So, if things hold up at 3 and 6 months real time you can probably trust them over longer timeframes.
If Pfizer has a short-list of candidates back in May, they could have had 6 months of stability data at approval.
They can keep those studies going and by next May have 12 months of data for the FDA to review and potentially update the transportation and storage requirements.
https://www.pharmacytimes.com/news/some-medications-last-lon...
https://www.astho.org/Programs/Preparedness/Public-Health-Em...