Crossing the Chasm: Pharmacometrics is a “Must Do” for a Successful Drug Program

Successful drug development and commercialization requires getting critical decisions right—what is the exposure-response relationship for the drug, what is the optimal dosing strategy, and which patients would derive greatest benefit from it. Pharmacometrics uses mathematical and statistical models to quantify drug, disease, and trial information to help address these decisions. The data used to build pharmacometric models comes from both internal pre-clinical and clinical data as well as external data on competitor drugs in the same class. Pharmacometrics increases our understanding of the internal and external factors that drive pharmacokinetic (PK) and pharmacodynamic (PD) variability. A well-designed pharmacometric strategy can also integrate knowledge across a drug’s pre-clinical and clinical development to support a “learn and confirm” paradigm.

Our PK/PD modeling and simulation services include:

Key benefits of this approach include:

  • Making data-driven decisions at all stages of drug development through a quantitative framework
  • Designing safer, targeted, and more efficient trials
  • Selecting the right dose for the right patients, the first time
  • Maximizing the probability of commercial success

Regulatory Inflection Point for Pharmacometrics

90%+ of all novel drugs approved by the US FDA over the past few years have leveraged pharmacometrics in their development program (most leveraging Certara’s services or technology.

Certara’s Integrated Pharmacometric Solutions

Certara provides high-quality, regulatory-compliant PK/PD analyses and modeling for regulatory submission packages. Our pharmacometricians support pre-clinical and clinical study analysis for new drug approvals, line extensions, in-licensing options, and product portfolio decisions for global biopharm companies.

With the largest global team of PhD, PharmD and MD consultants in the world, we leverage quantitative methods to build a comprehensive knowledge-base of drug discovery, pre-clinical, early-phase clinical, literature, and competitor data, which can be used to optimize decisions in later development, including the “go/no go” that will lead to commercial activities. These analyses can also inform post-approval study decisions.

Contact us to learn how our team of data management experts, pharmacometricians, and program managers can help you increase the efficiency and certainty of your drug program.