PK/PD is a Proven Approach

PK/PD models have proven to be an effective approach in thousands of applications in essentially all disease areas and phases of clinical development. Many larger biopharmaceutical organizations have developed their own internal capability to perform this type of modeling, and the FDA recently created the Division of Pharmacometrics to review these and other types of models.

In general, PK/PD models are most useful when there are sufficient clinical data or a clear method for animal-human or human-human scaling. When these conditions are not met, PK/PD models are less informative. This limitation motivated Rosa to create its innovative PhysioPD™ approach.

PK/PD Data Sources

PK/PD models integrate information from many sources that are otherwise difficult to compose into a comprehensive mental model. This integration into an explicit mathematical model provides clients with a better understanding of drug effect and more confidence in future trial outcomes.

Typical examples of PK/PD data sources include proprietary animal or clinical data regarding the drug or similar drugs, regulatory SBAs or other published studies on the effects of competing drugs, or literature related to the mechanism of action or the pharmacokinetics of the drug.

PK/PD Modeling Process

The process of modeling is as important as the resulting model.

Rosa’s deliberate, collaborative approach and experienced professionals ensure that our models are customized to our clients’ decision-making needs, yield defensible insights that compliment their expert judgment, and enable their organization to take confident action.

Rosa models are built on publicly-available, third-party modeling software. Our clients receive the finished model, and during the project, acquire the capability to use it, if they wish.