Services

What Should Your Dose Be?

For first-in-human studies or for commercialization, Simulations Plus uses a model-based approach to guide the selection of dosing and determine exposure-response relationships.

PK and Exposure-Response Model Development

With population-based pharmacokinetic models, we can characterize drug disposition using sparse drug concentration data on patients with the condition of interest, whereas the relationships between drug exposure and patient response are characterized 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.

 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.

Strategic Gap Analyses and Analysis Planning

In order to fully integrate model-based drug development into development programs, pharmacometricians must become highly skilled in strategically implementing modeling and simulation approaches across the entire development program, as well as in effectively communicating the value of modeling and simulation findings to support the decision-making milestones of research and development project teams. Simulations Plus will work with your pharmacometric teams by providing the best tools and techniques for strategic and operational gap analyses that assess the readiness of franchise programs in specific therapeutic areas to adopt model-based drug development.

Pharmaceutical and Clinical Pharmacology Consulting

We can assist your development team in all aspects of pharmacology, from the study design of preclinical studies to the 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 case for approval and acceptance from regulatory agencies and clinical practitioners.