Post by MnkdWASmyRtrmntPlan on Apr 7, 2022 12:53:20 GMT -5
Right, the priorities are true. And, compared to a study on kids, this study couldn't be difficult or expensive at all, and of course, it could be done simultaneously with the kids study. Studies with people cost a lot of money (kids would probably cost even more). Comparing A1c and/or Time in Range for long periods with the incredibly varied types of foods kids eat. Getting regular checkups with the administrators. I don't know what all is performed or exactly how those studies are done, but it must be pretty complicated and we know they cost lots.
Compare that to a study for temperature-moderated storage. These controlled temperature tests to determine if drugs can survive without refrigeration have been done so many times in the past for so many drugs and the FDA probably provides instructions, or at least guidelines on what they want to see. So, obtain those instructions and determine how many different temperatures and length(s) of time a drug (insulin) needs to be stored for.
1. obtain or create that many regulated thermal boxes RTBs (ex. one small refrigerator and some number of warm/hot RTBs, each set to various temperatures (70, 80, 90, 100, 110, etc). They might want to provide temperature guidance on the label. Ex, can be stored at temperatures up to 80. Otherwise refrigerate.
2. fill each of the RTBs with Afrezza samples.
... wait for it ...
3. come back in 30, 60, 90, 120, etc. days and remove the Afrezzas.
4. test them to determine if they are still valid.
5. write up the studies, provide them to the FDA and wait for approval.
It's that easy. Trust me, I've done this so many times ... ok, no I haven't, I pulled that out of my arse. But, compared to monitoring kids, this study must be easy/peesy and so much cheaper.
Compare that to a study for temperature-moderated storage. These controlled temperature tests to determine if drugs can survive without refrigeration have been done so many times in the past for so many drugs and the FDA probably provides instructions, or at least guidelines on what they want to see. So, obtain those instructions and determine how many different temperatures and length(s) of time a drug (insulin) needs to be stored for.
1. obtain or create that many regulated thermal boxes RTBs (ex. one small refrigerator and some number of warm/hot RTBs, each set to various temperatures (70, 80, 90, 100, 110, etc). They might want to provide temperature guidance on the label. Ex, can be stored at temperatures up to 80. Otherwise refrigerate.
2. fill each of the RTBs with Afrezza samples.
... wait for it ...
3. come back in 30, 60, 90, 120, etc. days and remove the Afrezzas.
4. test them to determine if they are still valid.
5. write up the studies, provide them to the FDA and wait for approval.
It's that easy. Trust me, I've done this so many times ... ok, no I haven't, I pulled that out of my arse. But, compared to monitoring kids, this study must be easy/peesy and so much cheaper.
