Pharmacometrics
Pharmacometrics Services
High-quality, regulatory-compliant analysis
Pharmacometrics modeling increases our understanding of key factors by leveraging quantitative methods.
Pharmacometrics services use mathematical modeling to quantify interactions between drugs and patients, and it helps optimize drug development and regulatory decisions. Understanding a drug’s benefit-risk profile in a target patient population is key for a successful drug. Pharmacometrics combines various modeling approaches to integrate relevant data that enable the characterization of the efficacy, safety, and biomarker responses of a new drug. The specific applications of pharmacometrics models will evolve during the course of development, and typical questions that they help answer are:
- Selecting doses and dosing regimens for future clinical studies
- Identification of patient factors that impact safety or efficacy
- Optimizing clinical study designs for optimal information content
- Developing, selecting, and optimizing drug formulation
Choose Certara: World’s Largest Pharmacometrics Team
With over 120+ pharmacometricians, the Certara Pharmacometrics team designs and implements MIDD strategies for all types of drug development programs, regardless of therapeutic area, drug modality, and development phase.
Optimize go/no-go decisions
Certara provides high-quality, regulatory-compliant pharmacokinetic and pharmacodynamic (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
- Product portfolio decisions
With the largest global team of PhD, PharmD and MD consultants, 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, including the “go/no go” that will lead to commercial activities.
These analyses can also inform post-approval study decisions.
Benefits of quantitative approaches
90%+ of all novel drugs approved by the US FDA over the past few years have used pharmacometrics in their development program, with most leveraging Certara’s services or technology.
- Make data-driven decisions at all stages of drug development through a quantitative framework
- Design safer, targeted, and more efficient trials
- Select the right dose for the right patients, the first time
- Maximize the probability of commercial success
Modeling is only as good as your data
Want to ensure the highest quality dataset for your analysis? Certara’s data programmers are experts in using SAS to code pharmacokinetic and pharmacodynamic (PK/PD) datasets.
- Our data programmers create datasets for our projects
- We create higher quality datasets that require fewer quality control cycles.
- We can decrease the time between database lock and performing noncompartmental analysis (NCA), exploratory analysis, or PK/PD modeling
Meet the Experts
Rik de Greef
Senior Vice President, Global Lead, Quantitative Science Services
Stephen Duffull
Senior Scientific Advisor, Quantitative Science Services
Matt Zierhut
Vice President, MBMA Capability Lead
JF Marier
Senior Vice President, Canada Region Lead, Quantitative Science Services
Adekemi Taylor
Vice President, QSS-US-1 Region Lead, Quantitative Science Services
Mirjam Trame
Vice President, QSS-US-2 Region Lead, Quantitative Science Services
Amy Cheung
Vice President, Europe/APAC Region Lead, Quantitative Science
Paul Diderichsen
Vice President, Europe/Africa Region Lead, Quantitative Science Services