YOU need just 2-3 weeks of experiments at accelerated conditions, 1 week for samples analyzed in one UPLC or HPLC run and one week to complete the documentation.
ASAPprime® allows users to predict shelf-life of a drug product and a drug substance quickly and accurately. Generally speaking, shelf-life calculation is based on the time that a drug product remains within specification limits under well-defined storage conditions. Standard ICH analyses typically require two to six months of laboratory data collection and use a linear extrapolation of data derived from a very narrow range of temperatures.
In contrast, the data required for the ASAPprime® software protocols can be gathered in as little as two to four weeks while utilizing a significantly wider range of conditions – both temperature and relative humidity are varied in a designed fashion.
ASAP supports gaining insights into degradation mechanisms, the evaluation of changes in manufacturing processes, the evaluation of excipient and API variations, rationales for purity specifications and effective packaging selection. As a result, ASAP accelerates the clinical launch of an API. It reduces the number of packaging screening studies needed to support product registration and the number of ICH stability study re-runs.
The program can be also used for comparison of experimental result with the predictions from ASAPprime®, for the calculation of the effect of the changes in the temperature and humidity conditions on product shelf-life (excursions) and also has a database of bottle and blister permeability values as a function of temperature to correct dosage form size (for blisters) and the storage temperature.
2-4 weeks vs. ICH-based standard of 2-6 months
Accurately assess stability and shelf life variation between product lots
Provides better insights into packaging and formulation/process choices. Replaces or supplements ICH-based studies for FDA and other regulatory agencies world-wide
Eliminates screening and allows for zone packaging selection.