Population pharmacokinetics (popPK) applies in early development when transitioning from nonclinical to first-in-human trials.
Pharmacometrics increases our understanding of key factors
Leverage quantitative methodsSuccessful drug development and commercialization requires getting critical development and regulatory decisions right.
- What is the exposure-response relationship for the drug?
- What is the optimal dosing strategy?
- Which patients would derive greatest benefit from this drug?
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 preclinical and clinical data as well as external data on competitor drugs in the same class.
Pharmacometrics increases our understanding of factors that drive pharmacokinetic (PK) and pharmacodynamic (PD) variability. A well-designed pharmacometric strategy can also integrate knowledge across a drug’s preclinical and clinical development to support a “learn and confirm” paradigm.
We partner closely with clients, forming one cohesive and integrated team. What our clients say:
“What I like most about Certara is not only their expertise, but also their commitment to their client.” – Clinical PK Manager at pharmaceutical company based in Switzerland
“What stands out about Certara is their timely responses and open dialogue.” – Translational Scientific Manager at mRNA therapeutics biotech
Noncompartmental analysis (NCA) is used to estimate PK and toxicokinetic (TK) parameters (e.g., clearance, Tmax, and Cmax)
Clinical trial design for pediatric development poses challenges – one can’t take an adult trial protocol and simply retool it.
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
JF has 25 years of experience performing PK, PK/PD and exposure-response analyses to support dosing rationale in various therapeutic areas. Specialties include oncology, rare diseases and pediatric populations. Over the last decade, he has provided pharmacometric analyses and strategic decisions that supported the regulatory approval of more than 25 small and large molecules.
Rik de Greef is a Senior VicePresident of Global Quantitative Science Services at Certara. Rik was trained as a PK-PD scientist at Leiden University, The Netherlands.
Over the years, Rik has taken on roles with increasing responsibilities within Organon and its successor companies Schering-Plough and Merck/MSD. Most recently, has was site lead for Clinical PK-PD. In this role he has led the expansion of the group from 15 to 34 coworkers. Also, he has led the preparations of the early clinical components of the BLA submission for Merck’s key program in oncology, pembrolizumab.
Mirjam, a pharmacometrics consultant, serves as the US Lead for Pharmacometrics, Division II, at Certara. With expertise spanning various modalities, including complex biologics, she specializes in Cell and Gene Therapy. Before joining Certara in 2022, Mirjam amassed over 18 years of experience in clinical pharmacology, pharmacometrics, and systems pharmacology, with a dedicated focus on Cell and Gene Therapy for over 5 years.
JF has 25 years of experience performing PK, PK/PD and exposure-response analyses to support dosing rationale in various therapeutic areas. Specialties include oncology, rare diseases and pediatric populations. Over the last decade, he has provided pharmacometric analyses and strategic decisions that supported the regulatory approval of more than 25 small and large molecules.
Rik de Greef is a Senior VicePresident of Global Quantitative Science Services at Certara. Rik was trained as a PK-PD scientist at Leiden University, The Netherlands.
Over the years, Rik has taken on roles with increasing responsibilities within Organon and its successor companies Schering-Plough and Merck/MSD. Most recently, has was site lead for Clinical PK-PD. In this role he has led the expansion of the group from 15 to 34 coworkers. Also, he has led the preparations of the early clinical components of the BLA submission for Merck’s key program in oncology, pembrolizumab.
Mirjam, a pharmacometrics consultant, serves as the US Lead for Pharmacometrics, Division II, at Certara. With expertise spanning various modalities, including complex biologics, she specializes in Cell and Gene Therapy. Before joining Certara in 2022, Mirjam amassed over 18 years of experience in clinical pharmacology, pharmacometrics, and systems pharmacology, with a dedicated focus on Cell and Gene Therapy for over 5 years.