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Pharmacometrics

Pharmacometrics services

Pharmacometrics Services

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. 

Pharmacometrics modeling services
Pharmacometrics modeling services

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 
Pharmacometrics modeling services

Meet the Experts

Rik de Greef

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

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