Label Optimization

Drug Label Optimization Using Proven Modeling and Simulation Methodology

The drug label is the culmination of years of work and millions, if not billions of dollars. Every inclusion and exclusion on that label will have a direct impact on the drug’s profitability.

While modeling and simulation have been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of physiologically-based pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than fifteen cases, driving down R&D costs and timelines, and allowing for greater population inclusion within the label.

Certara has been at the forefront of this evolution, working with sponsor companies and regulators to prove that modeling and simulation can deliver the return on investment. From guiding clinical study designs with smaller and more precise trials to the waiving of studies, including drug-drug interactions (DDI) and special populations, Certara’s label optimization services provide unquestionable value. These services comprise both mechanistic modeling (bottom up) and pharmacokinetic-pharmacodynamic PK/PD modeling (top down), along with regulatory consulting focused on guiding regulatory interactions around optimizing your drug label.


As published in Clinical Leader, “Conducting Virtual Trials Using PBPK To Drive More Precise Label Claims”
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