We recently changed the navigation and look of our website to show that we are a full-service drug development company. 505(b)(2) drug development is so much more than just regulatory submissions! I was asked to explain what the chart is on the pharmacokinetics services ‘page’:
The chart is a result of pharmacokinetic modeling. Note the title: Treatments A &B: Simulated and Actual Data. Modeling is using existing data, usually human pharmacokinetic data (and sometimes in vitro dissolution data) and performing simulations. For example, using data from a single-dose study to predict what a multiple-dose, steady state study would look like. This helps assess what formulation changes might be needed to achieve therapeutic effectiveness while meeting safety parameters.