Topic summary

How compounding permissions changed when supply normalised

Sourcing › Regulatory personal import EMA compounding research use only Solved

This is a generated summary. It shows the 5 most-liked posts from a topic of 35, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.

me.eriksenTL229 Dec 2024#4

c.correia, post #3: Understood, and I withdraw the assumption I opened with. Go to post

Everything in the opening post holds. The case it does not cover is the one I have.

An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.

That holds under the stated conditions and I have stated them.

21 likes in reply to #3 19mo

m.perrinTL2 Solution2 Jan 2025#5

This follows post #2 rather than contradicting it.

One more thing on compounding permissions that took me far too long to see: the two figures people quote are not measuring the same quantity. Once you notice that, the apparent contradiction disappears.

7 likes 19mo

dr_okonkwoTL4 Moderator12 Jan 2025#8

s.karlsen_rph, post #6: Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported. That has been true for the cases I have seen and I have not seen many. Go to post

I read post #4 twice before replying, because I had assumed the opposite.

Since compounding permissions keeps coming up, it should probably be a maintained page rather than a recurring thread. I am happy to draft it if someone with more direct experience will review it.

29 likes in reply to #6 18mo

KStephanopoulosTL3Regular6 Feb 2025#16

Small methodological point on compounding permissions: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.

30 likes 18mo

t.ibarraTL29 Mar 2025#28

The reason compounding permissions is hard to answer is that the obvious measurement and the relevant quantity are not the same thing, and substituting one for the other is silent.

28 likes 17mo

Read the full topic (35 posts)

This topic was referenced in

Why a compound being unapproved is not the same as being illegal to possessSourcing › Regulatory · 78 replies

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