Clinical Trial Supply MKT Calculator

Investigational products follow the storage condition in the protocol and IMP label; MKT is used to assess excursions at depots, sites and during patient distribution. The authoritative limit is whatever your product's labelled storage condition and stability data specify — read it off the marketing authorisation, the manufacturer's storage statement or the governing pharmacopoeia, and enter your real temperature history against it.

The sponsor's qualified person / quality function, against the product's stability data and the protocol's storage condition — not the site. Capture the excursion's full temperature/time profile and compute the MKT and excursion dose; the QA assessment compares these to the IMP's stability budget. Many excursions are within the product's demonstrated stability and the supply can be released with documentation; others require quarantine and disposition. The value of MKT here is enabling a scientific, documented decision rather than discarding scarce investigational supply by default.

Because degradation is not linear with temperature — it accelerates roughly exponentially (Arrhenius). A simple average treats an hour at 30 °C the same as an hour at 20 °C either side of 25 °C, but the product is harmed far more by the hot hour. MKT weights each reading by exp(−ΔH/RT), so it reflects the true cumulative chemical stress. It is always ≥ the arithmetic mean, and it is the figure regulators expect for storage and distribution compliance.

Use a representative series with durations — typically the logger's interval readings, or summarised blocks of 'X hours at Y °C' if you only have an excursion summary. The more granular the data, the more accurate the MKT, but the result is dominated by the warm excursions, so capturing those accurately matters most. Don't average data before entering it — that defeats the point; enter the temperatures and let the calculator do the kinetic weighting.