SURPASS-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.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 4 of 5 of this archive, newest first.
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Receptor pharmacology is strong on average effects and almost silent on individual variation. That gap is where most reader questions live.
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
Dose reduction is not withdrawal, and the trials that tested withdrawal cannot be read as testing it.
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The route did not close because of a rule about peptides.
The observation that closes a facility is rarely the dramatic one.
Follow the resin, not the catalogue.
Repeated injection into the same small area produces lipohypertrophy — thickened, rubbery subcutaneous tissue with blunted and erratic absorption. It is common, it is…
Concentrations fall by half a week, so a month away leaves a small fraction of steady state. Resuming at the previous dose presents the receptor with a step it has not seen…
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The route did not close because of a rule about peptides.
A proper account of an operation that existed, and of what closing it cost.
The result is unremarkable. What the report omits is not.
Dye ingress and microbial immersion are probabilistic. Vacuum decay, high-voltage leak detection and helium mass spectrometry are deterministic and far more sensitive.
The route did not close because of a rule about peptides.
The evidence base is thin and the document says so, which is to its credit.
The observation that closes a facility is rarely the dramatic one.
A reminder that a purity figure is the output of a method, and that methods differ.
A peptide has a monoisotopic mass and an average mass, they differ by several daltons at this molecular size, and a certificate that does not say which it quotes cannot be…
What the published pharmacokinetics permit, what the labels state, and where the two diverge.
Every withdrawal trial compared full dose against nothing. The clinically interesting comparison — full dose against a reduced one — has not been randomised.
A design note rather than a result: what the comparator was, and what that permits you to conclude.
Reported from the analysis, not from a warning notice.
Reported from the sessions, and from the two hours afterwards.
The gap between a defensible recommendation and a confident one is where most of the harm in this subject lives.
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
Follow the resin, not the catalogue.
Efficacy was never the question in this appraisal. Duration of treatment was.
A proper account of an operation that existed, and of what closing it cost.
The document is four pages. Three of them are about dates.
Lyophilisation does not stop degradation. It slows every pathway by removing the solvent that most of them require, and the residue of solvent that remains sets the rate.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
The evidence base is thin and the document says so, which is to its credit.
Reported from the sessions, and from the two hours afterwards.
A proper account of an operation that existed, and of what closing it cost.
The document is four pages. Three of them are about dates.
Head-to-head data exists for some of these comparisons and not for others. This piece says which.
A single drug producing both constipation and diarrhoea looks contradictory until the motility data is read properly.
The evidence base is thin and the document says so, which is to its credit.