Population Pharmacokinetic Pharmacodynamic Modeling & Simulation

We utilize population PKPD modeling & simulation to support various decision making during drug development.  Population PKPD modeling & simulation can also be utilized to  explore and defend appropriate doses in special populations such as pediatrics, chronic renal impairment and the elderly.

We are experts in exposure-response analyses to guide and defend dose selection decisions.  We have extensive experience across many exposure-response modeling approaches including logistic regression, tumor kinetic and time to event models. 

Collecting informative data during clinical studies is paramount to informed decision making.  We use quantitative approaches to guide PK/PD sample collection optimization for upcoming studies to balance resources & study practicalities with collection of informative data.  

Our consultants have been involved in numerous successful NDA and BLA filings.  We can develop submission ready pharmacometric packages and have an in-depth knowledge of the requirements and expectations of the regulatory agencies to streamline the approval process. 

We can help you with many aspects of clinical trial design to ensure adequate data is collected to inform all quantitative analyses and decision making.  Ensuring adequate data is collected across sufficient dose levels is paramount to a successful drug development process.

Our team can develop analysis ready datasets for all population PKPD and exposure-response analyses.  We have experience in creating all the datasets and defined files required for regulatory submission and interactions.