The pharmacometric approach is applied iteratively throughout the drug development process.
At each stage in the process, the relevant data is integrated to build models describing the current state of knowledge. This is the learning part of the iteration cycle.
Next, these models are used to simulate strategic alternatives, producing quantified risk assessments of each option.
Data collected from subsequent trials are then used to confirm and improve the accuracy of the models. In this way, as the process moves forward, the ability to quantify development risks in each step become more and more refined.
Better Decisions Throughout Drug Development
|Early Phases||Later Phases|
|Characterize drug exposure||Support FDA meetings and filings with clear rationale for recommendations|
|Optimize dose and dose frequency||Choose study populations and target different markets|
|Determine alternative drug formulations||Define difficult tradeoffs: probability of success, time to market and value of larger trials|
|Evaluate alternate clinical trial designs before investing||Pricing decisions, In/Out licensing decisions, due-diligence|