PIONEER 6 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The archive — 2024
Page 44 of 68 of this archive, newest first.
How to audit an identity claim in five minutes
The regulated world states the method, the instrument, the convention and the tolerance. This market states a verdict.
Units, millilitres, milligrams: three scales on one small object
Insulin syringes are graduated in units on a convention that fixes 100 units to one millilitre. That convention says nothing about how much peptide is in a unit, and…
Inspectors cite the relabeller trading as Vantris Bio over sterility assurance
The observation that closes a facility is rarely the dramatic one.
New Zealand caps semaglutide prescribing to 13 specialist centres
Efficacy was never the question in this appraisal. Duration of treatment was.
What changed at ERP in May, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Background rates, and why they matter for attribution
A small number of serious gastrointestinal events occur in people taking these drugs. Distinguishing them from the expected effect profile is the most consequential…
The eighteenth month, and the conversation that should have happened in the third
Weight reduction in the long programmes flattens at roughly sixty to seventy-two weeks. The timing is consistent, predictable and almost never mentioned in advance.
The dose that got you here and the dose that keeps you here
Every withdrawal trial compared full dose against nothing. The clinically interesting comparison — full dose against a reduced one — has not been randomised.
Australia health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
The consolidator trading as Meridian Freight Partners closes after 14 years
A proper account of an operation that existed, and of what closing it cost.
The 22-day notice: how a compounding wind-down works in Norway
The document is four pages. Three of them are about dates.
What the new Australia guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
The online reseller trading as Adamant Research Supply enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
A supplier suspends shipping to Turkey after 22 consecutive customs detentions
The route did not close because of a rule about peptides.
TRIUMPH-1 misses on a secondary endpoint the coverage has not mentioned
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The fourteen-day problem, and what it does to a commercial testing model
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
Tapering: a word borrowed from drugs with withdrawal syndromes
These agents produce no dependence and no withdrawal syndrome. What a taper would be for is therefore a real question rather than an obvious one.
The relabeller trading as Vantris Bio closes after 8 years
A proper account of an operation that existed, and of what closing it cost.
What the new France guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
What a 16% rise in coupling-reagent prices does to a 2 mg vial
Follow the resin, not the catalogue.
What a mass spectrometer does to a peptide before it measures anything
The ionisation method determines the charge states you see, the adducts you must account for, and the modifications you might destroy in the process.
Target dose, effective dose, and the distance between them
What the trials measured was continuation against withdrawal. What patients want to know is continuation at a lower dose, and that study has largely not been done.
Why summer is a documented quality problem in this trade
The route did not close because of a rule about peptides.
Calder Vale Peptides of Skipton closes after 11 years
A proper account of an operation that existed, and of what closing it cost.
Poland declines to reimburse liraglutide outside a specialist service
Efficacy was never the question in this appraisal. Duration of treatment was.
SGN declines, for the 12th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reading HbA1c in the presence of anaemia
A robust, cheap, standardised assay with a specific and well-catalogued set of failure modes, several of which are common in this population.