3 ms·
Unfortunately, ALT is not a solution, because it's not accepted by FDA, except as a temporary measure. Any drug submission that supports shelf life via ALT dat
by seehafer 9y ago
Unfortunately, ALT is not a solution, because it's not accepted by FDA, except as a temporary measure.
Any drug submission that supports shelf life via ALT data will be expected to also say "and we're doing real time testing to support this", and FDA will expect the follow up real-time data.
- GordonS 9y agoThen perhaps the solution is for the FDA to allow HALT testing. Having said that, I imagine there is little incentive for pharma companies to willingly extend the shelf life of their products - perhaps the real solution is for the FDA to actually require HALT testing.
- Broken_Hippo 9y agoI think the real thing here is, "Better safe than sorry". It's fine to use things like HALT testing initially to say, "this drug should be effective for 8 years" so that folks can get it to market before 8 years have passed. But if, in reality, that drug only lasts for a strong 5 years, after which time it loses effectiveness, especially in high humidity or with high UV exposure. We could catch this with real-time tests and adjust accordingly - before it actually affects the general public's health.