Blog & Resources Camargo Blog August 21st, 2008

PK Modeling, Not Just Any Pretty Face

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.

Many thanks to our intern, Sunny Tse for conducting this modeling.

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