We see it coming.
Moving from drug discovery into clinical development brings uncertainty.
So let us remove uncertainty from the equation.
We are committed to the principles of translational medicine — using PK-PD to integrate preclinical and clinical data through PK-PD modeling and simulation. This allows us to anticipate the roadblocks and present solutions, answering pivotal questions along the way.
And we set the pace.
In fact, we frequently contribute to regulator workshops, guidance documents, and treatment guidelines.
Our analyses are regularly used to support dose regimen selection, susceptibility breakpoint, and go-no-go decisions. Sponsors call upon us to shed light on program failures and provide understanding of the efficacy and safety of new agents.
This is how we continue to raise the bar time after time. Just consider some of what we do.
- Monte Carlo simulation, including clinical trial simulation
- Individual and population PK and PK-PD model development
- Optimization of PK study design
- Dosing guideline development
- Sparse PK sampling
- Optimized PK-PD study design
- Pre-clinical and clinical PK-PD model development
- Joint pre-clinical and clinical Bayesian PK-PD model development
- Monte Carlo simulation supporting dose-selection and susceptibility test interpretive criteria