PK/PD Support for Drug Approvals
Pharmacometrics: From “nice to have” to “must have” technology
Model informed drug development and discovery—which includes both top-down pharmacokinetic/pharmacodynamic (PK/PD) modeling and bottom-up, mechanistic approaches―continues to profoundly impact drug development by informing key decisions and labeling. 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
A review of the 45 drugs approved by the FDA in 2015 reveals that >90% used model informed drug development technology (as documented within the Office of Clinical Pharmacology reports) to inform the drug label. This trend aligns with the guidance documents emerging from global regulators, starting with the 1999 FDA guidance on the use of population pharmacokinetic analysis. Global regulators are also integrating the pharmacometrics tools of population PK, exposure-response, and PBPK into their review and approval cycles.
Supporting your PK/PD modeling and simulation needs
Certara Strategic Consulting 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 more than 100 client engagements per year.
Certara Strategic Consulting has the largest global team of consultants that leverage these quantitative methods for building 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.
Our work allows knowledge and wisdom to be carried over from one phase of the drug development process to the next. The companies that benefit most from this approach will systematically integrate the technology across all phases and tap into what has been known about a drug candidate to optimize clinical trials.
Integrated pharmacometric solutions
With our range of services, we can provide a work product tailored to the specific needs of each client, ensuring that the modeling & simulation deliverables are embedded in the overall development workflow to optimize the impact of the work.
Our PK/PD modeling and simulation services include:
- Non-compartmental analysis (NCA) – sparse or rich data analysis
- Compartmental analysis – semi-physiological PK/PD modeling
- Population PK/PD analysis
- Exposure-response modeling
- Tumor modeling
- Clinical trials simulation
We can support your strategic drug development decisions and new drug approvals through quantitative analysis and predictive models of diseases, drugs and clinical trials.