Freezing a reconstituted vial: the ice-water interface problem
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
The archive
Page 79 of 170 of this archive, newest first.
What a 34% rise in coupling-reagent prices does to a 5 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.
The quiet end of the relabeller trading as Vantris Bio
A proper account of an operation that existed, and of what closing it cost.
A shortage listing ends. 19 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
What SURMOUNT-1 tells us about maintenance, and what it does not
The commonest real-world strategy in this drug class is the least studied one.
Do you need the top of the ladder?
A plateau at an intermediate dose and a plateau at the maximum dose look identical from the outside and mean different things.
Sterility is not a percentage, which is the whole difficulty
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
The quiet end of the online reseller trading as Adamant Research Supply
A proper account of an operation that existed, and of what closing it cost.
Inspectors cite Calder Vale Peptides of Skipton over sterility assurance
The observation that closes a facility is rarely the dramatic one.
What the new the Netherlands guidance says about stopping
The evidence base is thin and the document says so, which is to its credit.
What the trial protocols permitted, and what the labels omitted
The practice is near-universal, clinically sensible, and supported by observational data rather than randomised comparison. We say which is which.
Inspectors cite Calder Vale Peptides of Skipton over sterility assurance
The observation that closes a facility is rarely the dramatic one.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
LEADER 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 shortage listing ends. 16 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
Two-thirds back: the extension nobody expected to be the headline
The evidence on stopping is better than the evidence on almost anything else in this field, because somebody deliberately randomised it.
Load, not cardio: the distinction the general advice keeps losing
The recommendation survives scrutiny. The reasoning offered for it frequently does not.
The consolidator trading as Meridian Freight Partners enters a consent decree and stops sterile preparation
The observation that closes a facility is rarely the dramatic one.
Independent analysis puts a KP liraglutide lot at 97.9%, against 97.0% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
SGN declines, for the 6th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The 29-day notice: how a compounding wind-down works in Norway
The document is four pages. Three of them are about dates.
Six words a verification badge would need to mean anything
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
Escalating onto a rising curve
We work the arithmetic out in full, because it is arithmetic and it is short.
KP declines, for the 24th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Norway health authority warns on falsified dulaglutide pens
Reported from the analysis, not from a warning notice.
A shortage listing ends. 10 pharmacies now have a business model and no legal basis for it.
The document is four pages. Three of them are about dates.
Fat mass fell more than lean mass. That is the finding, and it is not the headline.
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.
What the paperwork is for, and who it was designed to protect
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
What a 23% rise in coupling-reagent prices does to a 10 mg vial
Follow the resin, not the catalogue.