Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

Pharmacokinetic Modeling

Although silicon will never fully replace In Vivo studies in drug development, advanced computer models, in the hands of PharmaDirections experts, can dramatically streamline dosage form development. Our computer-assisted "rational formulation" approach puts our pharmacokineticists in the driver’s seat in optimizing products for enhanced bioavailability or controlled release.

Using all available data for your compound and a complete computer simulation of the GI tract, we develop a sophisticated model of drug absorption and disposition and use this model to guide the development of dosage forms meeting your objectives. This targeted approach results in quicker development, a reduced number of animal and/or clinical PK studies, and often in IP opportunities for our clients when unexpected results are generated In Silico and verified in Vivo.

Predictive PK modeling is also an excellent tool for assessing the feasibility of modified release dosage forms or bioavailability enhancement. Once a model is developed, a variety of release profiles and types of dosage forms can be tested in silico at minimal cost. In many cases we have provided our clients with data pivotal in convincing investors to support a modified release program. In other cases, we have saved clients from sinking millions into programs with little or no chance of success.

 Learn how PK modeling was used in reformulating a product for lifecycle extension

Download a free In Silico PK Modeling course