gPROMS FormulatedProducts contains powerful computational oral absorption simulation (COAS) tools for predicting drug absorption in the human intestine as a function of product formulation parameters and ingestion conditions.
This helps formulation scientists accurately predict oral absorption based on material physicochemical properties, prior to first-in-human trials.
It provides a means to easily and quickly screen new formulations, with the ultimate objective of designing a good dosage form, and explore the formulation decision space rapidly to identify risk factors, overcome liabilities and optimise the clinical trial pathway.
Because the COAS tools were developed in cooperation with leading pharmaceutical companies, they offer many advantages over prior approaches:
Identify risk factors prior to FIH trials
The gPROMS FormulatedProducts COAS tools are designed from the bottom up to simulate oral absorption based solely on measurable, physicochemical properties available before human, animal or even in vitro trials. Insights developed using the COAS tools become a guide to identify and mitigate risk factors, and ultimately to reduce the number of costly, time-consuming trials while also reducing unnecessary risk to test subjects.
Make better predictions based on better models
The high-fidelity, mechanistic models gPROMS FormulatedProducts make use of modelling methods well beyond the data fitting techniques commonly employed. An approach based on fundamental physics, chemistry and physiology allows the COAS tools to give unprecedented confidence in the accuracy of predictions.
Easily incorporate proprietary models
The gPROMS FormulatedProducts COAS tools include easy-to-use templates to incorporate custom kinetic equations for any process within the system. Formulation scientists can leverage prior R&D investments in specific areas of expertise while operating within an open, compatible simulation framework.
Accurately represent dynamic physiology
The gCOAS tools include preset physiologies and the explicit values that define the physiological environment. User-defined custom physiologies allow tremendous flexibility to choose the number of segments in the GI tract and the physiological conditions in each segment.
See interdependencies in open model reports
gCOAS is based on the powerful gPROMS platform which simultaneously solves all model equations while providing complete, fast access to all calculations throughout the simulation. Formulation scientists can see not just a result, but also the interdependencies and relationships that lead to the result. gPROMS FormulatedProducts gives you the clarity to make decisions with confidence.
Optimise the clinical trial pathway for increased R&D efficiency
As the pharmaceutical industry faces increasing pressure to bring new and better drugs to market earlier, the gFormulatedProducts COAS tools and complementary technologies help scientists improve predictions and reduce trials. Flexible, open models that predict performance over a range of conditions allow pharmaceutical scientists to explore the decision space rapidly, effectively and at low cost.