Discover the benefits of ASAPprime®
The team at Tepnel Pharma Services have introduced ASAPprime®, the only commercially-available software that allows for a remarkably accurate prediction of a product’s shelf-life and stability in as little as four weeks.
Stability studies are a time consuming and resource intensive task during the development of new drugs. Accelerated Stability Assessment Programme (ASAP) is an approach based on the Arrhenius equation whereby degradation increases with temperature and therefore using appropriate testing vessels and statistical analysis, it is possible to project the degradation rate at low temperature from the data generated under accelerated or stressed conditions.
Whilst the regulations require that long-term studies or real-time studies are still needed, ASAP provides an additional tool that can be applied through the whole life-cycle of the drug product, from development up to post-approval changes. Using ASAP helps to de-risk the development decision by enhancing predictive power and increasing confidence in product formulation shelf life, mitigating lifecycle risk management.