The lead-in, the randomisation, and the year that followed
Three randomised withdrawal designs have tested what happens when treatment stops. Their results are consistent and they are consistently misreported.
November 2024
Everything filed in November 2024, the month of Volume 1, Number 11. The issue itself — cover, editor’s letter and table of contents — is here.
Inspectors cite Calder Vale Peptides of Skipton over sterility assurance
The observation that closes a facility is rarely the dramatic one.
Germany health authority warns on falsified dulaglutide pens
Reported from the analysis, not from a warning notice.
STEP 2 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.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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.
Why no trial in this class has reported a strength endpoint
The composition data comes from imaging substudies enrolling a few score participants at selected sites. It is the best evidence available and it is thin.
Halvard & Pike Apothecary of Portland, Maine enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
Janoshik result on a Xianning semaglutide lot lands 4.3 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
PIONEER 6 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
What the new India guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
Check the vial, not the box
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
Every fortnight, every third week, seasonally: an unstudied practice
The schedules in circulation, described accurately, with their evidentiary status attached.
The quiet end of the consolidator trading as Meridian Freight Partners
A proper account of an operation that existed, and of what closing it cost.
Ireland health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
FGP declines, for the 4th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The Netherlands pharmacy body issues counselling standards for tirzepatide initiation
The evidence base is thin and the document says so, which is to its credit.
Why a drug that acts on the pancreas changes what food tastes like
A tour of the tissues where the receptor is expressed, and what happens in each.
Two documents, two disciplines: purity and sterility are not the same trade
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
The relabeller trading as Vantris Bio closes after 3 years
A proper account of an operation that existed, and of what closing it cost.
The United Arab Emirates caps exenatide prescribing to 19 specialist centres
Efficacy was never the question in this appraisal. Duration of treatment was.
What changed at WXT in November, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A shortage listing ends. 11 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
Non-responders, and the honest state of the evidence about them
The mechanism is well described. The variance is not.
What happens in solution that does not happen in the cake
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
Is semaglutide better than dulaglutide, or differently balanced?
What adding GIP activity does, on the current evidence, and what remains unresolved.
Singapore health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
STEP 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.
Why summer is a documented quality problem in this trade
The route did not close because of a rule about peptides.
What a split-sample exercise can establish, and what it cannot
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
QYB declines, for the 4th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Independent analysis puts a BCH mazdutide lot at 95.5%, against 94.0% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
A shortage listing ends. 9 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
The slide that was not in the abstract
Reported from the sessions, and from the two hours afterwards.
The retest date and the expiry date are not the same document
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
Priming a pen is not optional
Aseptic technique here is four steps and none of them are difficult. They are, however, routinely compressed to two.
TRIUMPH-1 extension data: what happens after the trial stops
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Saudi Arabia caps dulaglutide prescribing to 9 specialist centres
Efficacy was never the question in this appraisal. Duration of treatment was.
Inspectors cite the relabeller trading as Vantris Bio over sterility assurance
The observation that closes a facility is rarely the dramatic one.
The 20-day notice: how a compounding wind-down works in Sweden
The document is four pages. Three of them are about dates.
Disregard limits: what a regulated laboratory does with a tiny peak
Chromatographic software does not integrate every fluctuation in the baseline. It applies a threshold, and the threshold changes the reported purity by amounts that matter…