Inspectors cite Halvard & Pike Apothecary of Portland, Maine over sterility assurance
The observation that closes a facility is rarely the dramatic one.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 3 of 5 of this archive, newest first.
The observation that closes a facility is rarely the dramatic one.
Dose reduction is not withdrawal, and the trials that tested withdrawal cannot be read as testing it.
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 evidence base is thin and the document says so, which is to its credit.
A proper account of an operation that existed, and of what closing it cost.
Efficacy was never the question in this appraisal. Duration of treatment was.
Estimated glomerular filtration rate is a calculation with muscle mass in the denominator of its assumptions. In this population that matters.
Accreditation is granted for a defined scope of methods. A laboratory can be properly accredited and the test on your certificate can sit outside it.
The route did not close because of a rule about peptides.
Reported from the sessions, and from the two hours afterwards.
Efficacy was never the question in this appraisal. Duration of treatment was.
A design note rather than a result: what the comparator was, and what that permits you to conclude.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
A catalogue of open questions, with an assessment of how likely each is to be resolved.
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
The observation that closes a facility is rarely the dramatic one.
The document is four pages. Three of them are about dates.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A reminder that a purity figure is the output of a method, and that methods differ.
We set out the parameters a method disclosure would contain, all of which are known to whoever ran the sample and none of which is commercially sensitive.
A proper account of an operation that existed, and of what closing it cost.
The evidence base is thin and the document says so, which is to its credit.
Follow the resin, not the catalogue.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
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.
Sharps disposal is a legal obligation in most jurisdictions and a safety obligation everywhere. Household waste is not a route.
The supplier has not disputed the finding. It has not explained the gap either.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Efficacy was never the question in this appraisal. Duration of treatment was.
The intervention with the clearest evidence is the one nobody frames as an intervention: adjusting the dose.
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
Dead space in the needle hub is a real and calculable loss, and it matters more at small volumes than anybody expects.
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.
Micronutrient guidance for this drug class is borrowed almost entirely from post-bariatric surveillance, where the anatomy is different and the deficiency mechanisms are not…
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.