The incidence tables, read line by line
Trial adverse-event tables count episodes reported to a study nurse. They are the best data we have and they systematically under-record the mundane.
Marguerite Vasseur
Page 9 of 10 of this archive, newest first.
Archive — page 9
182 piecesThe one place the insulin literature and this class agree completely
Repeated injection into the same small area produces lipohypertrophy — thickened, rubbery subcutaneous tissue with blunted and erratic absorption. It is common, it is…
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.
What the upper limit of normal for ALT should be, and why it is not
Estimated glomerular filtration rate is a calculation with muscle mass in the denominator of its assumptions. In this population that matters.
SURPASS-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.
Holidays, surgery, sickness: interruption in practice
The convention — resume lower, re-escalate — is not caution. It follows directly from the elimination half-life.
The impurity hiding underneath the parent peak
The most useful single addition to any purity determination is a second separation under a different pH or on a different stationary phase, and the second-most useful is a…
STEP 5 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.
Why two wavelengths on one run would settle several arguments
Non-chromophoric components — counter-ions, salts, some excipients — contribute mass to the vial and nothing at all to the chromatogram.
The three-times-upper-limit convention, and where it came from
Asymptomatic pancreatic enzyme elevation is common on treatment and is not pancreatitis. The distinction is clinical, not biochemical.
What the GLP-1 receptor actually does when mazdutide binds it
Selectivity, potency and efficacy are three different measurements. The trade routinely reports none of them.
The specification sheet says 500,000. The report says conforms.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
SURMOUNT-2 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.
When a template becomes a misrepresentation
A blank certificate with the numbers left editable is an ordinary internal document. Its circulation as a finished record is the problem.
SURPASS-3 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.
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.
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 escalation table is the thinnest page in the label
The published ladder exists because a protocol needed a single number. Practice has never followed it exactly, and the regulatory file never assumed it would.
SURMOUNT-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.
A percentage is not a specification
Chromatographic purity is cheap, fast and comparable-looking. Those three properties, and not its usefulness, explain why it became the industry’s single figure of merit.