Research-use-only labelling: what it means and what it does not — the long version posts 91–120
This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.
Research-use-only material is not approved for human use anywhere. That is a statement about the material's regulatory category rather than about its quality.
Second-hand, so weight it accordingly.
Post #90 and I disagree about the size of the effect, not about the direction.
Second-hand on Research-use-only labelling, so weight it accordingly — someone whose method I trust told me this and I have not verified it myself.
Everything in post #93 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.
The bit of Research-use-only labelling that nobody enjoys is that the answer changes depending on what you are trying to decide with it. Say what the decision is and the thread will converge.
Labelling and intended use: a compound sold as "research-use-only" does not change its pharmacology if ingested. It changes the legal status of the sale. The labelling tells you the intended use, not the actual use people make of it.
I would want a second opinion before relying on that.
Agreed, and I will stop repeating the version of this I had been repeating.
The arithmetic in post #97 is right; the assumption feeding it is the part to check.
The honest answer on Research-use-only labelling is that it depends, and the useful part is the list of what it depends on. Four items, in rough order of how much they matter.
Most people get the first two right and then argue about the fourth.
Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.
Picking up post #101: that is the part I would want checked first.
Adding a reference point for Research-use-only labelling. Mine is a single case, collected without controls, and I am posting the method alongside it so it can be discounted appropriately.
The most useful reply I ever got about Research-use-only labelling was a request to state my units. It sounds like pedantry and it has saved me twice.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
It is the kind of thing that is obvious once and never again.
Worth separating two things that post #105 runs together.
Labelling and intended use: a compound sold as "research-use-only" does not change its pharmacology if ingested. It changes the legal status of the sale. The labelling tells you the intended use, not the actual use people make of it.
I would put a moderate confidence on that and no more.
On Research-use-only labelling I would separate what is worth knowing from what is worth acting on. The first list is long and the second is short, and conflating them is how threads get heated.
Where I part company with post #105, and it is a narrow parting.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
That is the honest state of it as of this week.
Saving this. It is the version I will quote when the question comes round again.
Adding the measurement that post #112 says would settle it.
If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.
Adding it because I spent an afternoon working it out and nobody should have to twice.
Research-use-only labelling was covered in the wiki last year and the page has a review date on it, which is a better starting point than my memory of a thread.
I had written a reply contradicting post #114 and deleted it. Here is what survived.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
Take the reasoning and check the arithmetic; I do not always get it right.
A label change is a regulatory event with a date and a document. Citing the document is what makes a claim about labelling checkable.
Taking post #116 at face value and following it one step further.
Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.
I keep a log of this specifically because memory is unreliable about it.
Helpful, and easy to find again, which is half of what a good reply is.