Inspectors cite the relabeller trading as Vantris Bio over sterility assurance
The observation that closes a facility is rarely the dramatic one.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Practice Dispatch
The evidence base is thin and the document says so, which is to its credit.
The pharmacy regulator in Singapore has issued counselling standards for initiation of GLP-1 receptor agonist therapy, specifying what must be covered at the point of supply: device technique, expected adverse effects, what to do about a missed dose, storage, sharps disposal, and — notably — what happens if treatment stops.
The titration document sets out three permissible responses to unresolved symptoms at a given dose: hold at the current dose for a further interval, return to the previous dose, or discontinue. It declines to specify a maximum hold duration, on the stated grounds that no evidence supports one.
The evidence base for most practical questions in this field is thin, and the better guidance documents say so explicitly rather than manufacturing a recommendation grade. The Journal reports the stated evidence quality alongside the recommendation, because a strong recommendation on low-quality evidence is a different object from a strong recommendation on high-quality evidence.
Ndidi Achebe, regulatory affairs consultant, noted who the document does not reach. "None of my patients who buy online will ever see this. That population is entirely outside the guidance system."
We have asked the issuing body whether the guidance will be reviewed on a fixed cycle and what would trigger an earlier revision.
The observation that closes a facility is rarely the dramatic one.
Roughly four to seven per cent of trial participants discontinued for adverse events, mostly gastrointestinal, mostly during escalation. That is the empirical size of the…
A single drug producing both constipation and diarrhoea looks contradictory until the motility data is read properly.
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.
The evidence base is thin and the document says so, which is to its credit.