Your new drug is going to change the world, right? That is, if it gets through the rigorous development process and the right dose is selected. What we do is increase your odds through the science of pharmacokinetics and pharmacodynamics. Simply put, our results arm you with the knowledge to successfully achieve critical milestones, the credibility to withstand regulatory scrutiny, and the confidence you will avoid costly surprises down the road. And it’s not difficult to understand how important all of that can be.
Clinical Trial Simulations
We use population PK/PD models to simulate a clinical trial, which can test the impact of study designs on trial outcomes. With this method, various “what if” scenarios can be evaluated with replication to provide confidence in designing future trials.
Pharmaceutical and Clinical Pharmacology Consulting
We can assist your development team in all aspects of pharmacology, from study design of preclinical studies to preparation of the pharmacology sections of your IND to non-compartmental pharmacokinetic and dose proportionality analyses. All of these activities are essential to build the story for approval and acceptance from regulatory agencies and clinical practitioners.
PK and Exposure-Response Model Development
Using population-based pharmacokinetic models, we can characterize drug disposition using sparse drug concentration data in patients with the condition of interest, whereas characterizing the relationships between drug exposure and patient response is done using exposure-response models. By gaining this understanding, we can support the selection or justification of dosing strategies, determine the maximum tolerated dose or the minimum effective dose, and characterize sub-population differences or drug-drug interaction effects for inclusion in the drug’s labeling information.
Strategic Gap Analyses and Analysis Planning
In order to fully integrate MBDD into development programs, pharmacometricians must become highly skilled in strategically implementing modeling and simulation (M&S) approaches across the entire development program and in effectively communicating the value of M&S findings to support the decision-making milestones of R&D project teams. Simulations Plus will work with your pharmacometric teams by providing the tools and techniques for performing strategic and operational gap analyses that assess the readiness of franchise programs in specific therapeutic areas to adopt MBDD.