Accelerated storage tests on pharmaceutical products: effect of error structure of assay and errors in recorded temperature.
The likely error structure for accelerated shelf-life studies is discussed. How to fit the Arrhenius relationship in the presence of this structure is shown and it is concluded that test potencies between 20% and 50% are likely to provide most information. The effect of temperature errors on the estimation of shelf-life is also considered.
D002626:Chemistry, Pharmaceutical / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D008956:Models, Chemical; D013696:Temperature