Modeling and Simulation

Doing the math really adds up.

Congratulations — you’ve just found the best kept secret in drug development. PK/PD analyses, model-based development strategies, and clinical trial simulations are crucial steps in reaching your product’s full potential. Our models bring together information about exposure and response to predict efficacy and safety outcomes in a clinical trial. And that’s not all. PK/PD modeling can also help identify knowledge gaps, support the selection or justification of dosing strategies, determine the maximum tolerated dose or the minimum effective dose, and characterize subpopulation differences or drug-to-drug interaction effects for inclusion in the labeling information. So what are you waiting for?

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.

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.

PBPK Modeling

Simulations Plus Buffalo NY and Lancaster CA offices offer physiologically based pharmacokinetic (PBPK) modeling and simulation consulting services using GastroPlus the pharmaceutical industry’s most sophisticated platform for the prediction of drug absorption and disposition in human and animal species.  We can work with you to:

  • Identify mechanistic explanations for unexplained variances in absorption characteristics and bioavailability results and use that information to guide population PK and PD modeling and simulation efforts
  • Predict drug behavior in pediatric patient populations and perform clinical trial simulations to ensure patient safety and optimize efficacy outcomes in clinical trials while minimizing number of subjects needed.
  • Perform PBPK modeling of preclinical data to define dosing strategies for First in Human (FIH) studies

And this is just the beginning   READ MORE


Pharmacometric 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. 

Completing modeling and simulation activities for a development program is an important first step in addressing team questions. The critical next step is to synthesize the modeling results into a compelling story that can inform and guide decision-making. In 2018, Cognigen worked on more than 40 development programs, each with their own story and 50% of the projects resulted in direct regulatory correspondence or interactions. Cognigen’s experience and expertise can help you prepare for the highly visible stress-inducing presentations to senior management or regulatory agencies.

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 approaches across the entire development program and in effectively communicating the value of Modeling and Simulation findings to support the decision-making milestones of research and development project teams. Cognigen 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.

Technical Report Writing

At Cognigen, we pride ourselves on the completeness of the technical reports we submit to regulatory authorities. Our goal is to minimize or eliminate the questions posed by regulatory reviews, while balancing the cost and time it takes to develop a report. Our reports also allow a new team or employee (or a company you license your drug to) to be able to know what was done and why - giving you confidence and reducing the need for rework.