SURMOUNT-4 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.
Archive — October 2024
Page 2 of 5 of this archive, newest first.
A shortage listing ends. 7 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
The quiet end of Halvard & Pike Apothecary of Portland, Maine
A proper account of an operation that existed, and of what closing it cost.
The United Arab Emirates caps tirzepatide prescribing to 22 specialist centres
Efficacy was never the question in this appraisal. Duration of treatment was.
What a laboratory knows about the material it receives
What a laboratory can and cannot know about the provenance, storage history and representativeness of what lands on its bench.
What a mass spectrometer does to a peptide before it measures anything
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
A supplier suspends shipping to Switzerland after 4 consecutive customs detentions
The route did not close because of a rule about peptides.
What a 9% rise in coupling-reagent prices does to a 20 mg vial
Follow the resin, not the catalogue.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Independent analysis puts a TFC dulaglutide lot at 95.8%, against 95.1% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The retest date and the expiry date are not the same document
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
The shelf life ends when the diluent goes in
At low concentrations a measurable fraction of peptide can adsorb to glass and plastic surfaces, and the loss is largest exactly where it is least expected.
The dose that got you here and the dose that keeps you here
The commonest real-world strategy in this drug class is the least studied one.
LEADER 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.
Independent analysis puts a ERP survodutide lot at 95.6%, against 92.3% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
The relabeller trading as Vantris Bio enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
Why the bone question is harder than the muscle question
Density is a proxy for strength and an imperfect one, particularly when soft-tissue thickness over the measurement site is changing.
What changed at QSC in October, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Janoshik result on a Shenzhen liraglutide lot lands 1.2 points above the supplier’s stated figure
The result is unremarkable. What the report states alongside it is not.
From the floor in Qingdao: 10 posters, one theme
Reported from the sessions, and from the two hours afterwards.
What the new Spain guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
The mechanism behind the mechanism
The receptor populations that produce satiety and the ones that produce nausea overlap substantially. That is why the ceiling of this drug class is where it is, and it is…
Asparagine, glycine, and the two residues that decide a shelf life
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
Independent analysis puts a FGP exenatide lot at 96.3%, against 92.6% on the certificate
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
FLOW 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 9-day notice: how a compounding wind-down works in Australia
The document is four pages. Three of them are about dates.
Inspectors cite the online reseller trading as Adamant Research Supply over sterility assurance
The observation that closes a facility is rarely the dramatic one.
Bone density during rapid weight loss: what is known, which is less than you would hope
The evidence base is one secondary analysis, several small studies and a large amount of extrapolation from bariatric surgery.
A supply gap is a pharmacological event
One omitted dose is a labelling question. Four omitted doses is a clinical one. The two are routinely conflated.
STEP 3 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.
A supplier suspends shipping to Norway after 18 consecutive customs detentions
The route did not close because of a rule about peptides.
The relabeller trading as Vantris Bio enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
Randomised withdrawal is the cleanest design in this field and the least discussed
The regain trajectories, arm by arm, with the estimands named.
Mapping a rotation that you will actually follow
Repeated injection into the same small area produces lipohypertrophy — thickened, rubbery subcutaneous tissue with blunted and erratic absorption. It is common, it is…
A shortage listing ends. 14 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
The 29-day notice: how a compounding wind-down works in Argentina
The document is four pages. Three of them are about dates.
Inspectors cite the online reseller trading as Adamant Research Supply over sterility assurance
The observation that closes a facility is rarely the dramatic one.
PeptideMeter result on a Guangzhou liraglutide lot lands 3.3 points above the supplier’s stated figure
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Asparagine, glycine, and the two residues that decide a shelf life
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
How a release document is put together in a regulated plant
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.