The one-quarter rule, and the paper that took it apart
Grading six widely repeated claims against the studies actually behind them.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 4 of 5 of this archive, newest first.
Grading six widely repeated claims against the studies actually behind them.
The physics of the drying cycle explains why some cakes are matte and full-volume and others are glassy discs, and why the difference is not cosmetic.
An assay against a quantitative reference standard measures how much is present. Area per cent measures what proportion of the visible material is the parent. Only the first…
The diluent choice affects preservation and in-use period rather than the arithmetic — but the wrong choice for a multi-dose vial is a sterility decision, not a convenience…
A 4 mm needle at ninety degrees without a skin pinch is adequate for essentially all adults. The persistence of 12.7 mm needles in this market is habit, not reasoning.
Dye ingress and microbial immersion are probabilistic. Vacuum decay, high-voltage leak detection and helium mass spectrometry are deterministic and far more sensitive.
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 Journal wrote to twenty companies asking five specific questions about sterility assurance. We report the response rate, the substance and the refusals.
We have catalogued what readers report, ranked by the size of the dosing error each produces.
Sharps disposal is a legal obligation in most jurisdictions and a safety obligation everywhere. Household waste is not a route.
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
What was pre-specified, what was exploratory, and what was calculated afterwards by people who did not run the trial.
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
Reduced intake is a plausible mechanism for deficiency. Reduced absorption is not, and the two are conflated in most of the advice.
Bioburden entering the filter, filter integrity, environmental monitoring and aseptic process simulation are the four pillars. The trade documents none of them.
An orthogonal method separates on a different physical principle, so that species co-eluting in the first are likely to resolve in the second. Two runs of the same method at…
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
What would be needed to catch each of these, and what it would cost.
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
A substudy powered to describe a mean is not a substudy powered to detect a clinically meaningful individual change.