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ForumsCompounding & FormulationCompounded tirzepatide formulation challenges — looking for input Page 9

Compounded tirzepatide formulation challenges — looking for input

Dr.EndoIndy Tue, Jul 9, 2024 at 8:50 AM 43 replies 2,583 viewsPage 9 of 9
KristenIndy
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Jul 21, 2024 at 6:27 AM#41
kate.chem said:
If you are going to change something, change one thing and give it long enough to express itself.

This is exactly what I could not find anywhere else. Adding it to my notes with a link back to this thread.

36 11LondonLisa, mike_nyc, VendorMark and 33 others
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TrialTracker_MD
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Jul 21, 2024 at 6:38 PM#42

From the other side of the consultation, briefly. There is a difference between no evidence and evidence of no effect, and this subject is one where the two get swapped freely in both directions.

Last edited: Jul 21, 2024 at 11:38 PM
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mike_mod
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Jul 22, 2024 at 6:49 AM#43

Moderator note: a couple of off-topic posts removed. Report rather than reply if it drifts again.

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cory_ATX
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Jul 22, 2024 at 7:01 PM#44
TrialTracker_MD said:
There is a difference between no evidence and evidence of no effect, and this subject is one where the two get swapped freely in both directions.

Coming at TrialTracker_MD’s question from a different direction. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.

Ask again with the specifics and you will get a better answer than this one.

Last edited: Jul 22, 2024 at 9:01 PM
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FDA_TrackerJim
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Jul 23, 2024 at 7:13 AM#45

One concrete data point for the thread. Give anything pharmacological four weeks before you judge it, and give anything measured weekly a four-point rolling average before you call it a trend.

32 7jason_paloalto, Dr.LeslieOBGYN, MikeNYC_runner and 29 others
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