Pharmacometric Services

Partnering with Pharmacometric Services at Cincinnati Children’s gives you access to unsurpassed pediatric-specific experience and expertise that can improve pediatric drug development and enhance regulatory decision-making to increase the success rate of your pediatric drug studies. By leveraging the Food & Drug Administration’s (FDA) emphasis on pharmacometric analysis, we can help you minimize time and cost by increasing accuracy, resulting in fewer or smaller clinical trials.

Why Partner with Cincinnati Children’s for Pharmacometric Services?

• With faculty who serves as an advisor on an FDA pediatric sub-committee, we offer clients extensive knowledge of the FDA review process.
• Our team can coordinate the entire process, from doing the study design and writing pediatric-specific clinical protocol to running protocol and analyzing data. This gives you one-stop convenience and provides the cost efficiencies of a single location.
• The Pharmacometric Services at Cincinnati Children’s offers extensive expertise in quantitative pharmacology and population Pharmacokinetic/Pharmacodynamic (PK/PD) modeling.
• Our pediatric-specific insight and experience can lead to the most effective study design, and optimize time-to-market for pediatric drug development, which reduces overall cost.
• Cincinnati Children’s has experience in several therapeutic areas including infectious disease, neurology, oncology, transplantations, and pain management.
• Because of our large center setting and access to patient populations, Cincinnati Children’s has the ability to be the lead site for your study.
• Our sophisticated modeling and simulation software enables better trial design and helps meet the challenges of a limited patient population.

Recognized as a Leader in Pediatric Research

Cincinnati Children’s is one of the world’s largest centers devoted to pediatric medical research, and one of the top U.S. pediatric medical centers receiving National Institutes of Health (NIH) research funding. We have experience with both the U.S. pediatric development plan and the European paediatric investigational plan. Our current pharmacometrics research interests include the developmental characteristics and genetic polymorphisms of drug metabolizing enzymes and receptors. Through our unique pharmacometrics R&D program and commitment to innovation, we are working to continually advance the technology behind pharmacometric analysis.

Available Pediatric Pharmacometric Services:

• Pediatric PK/PD modeling and simulation
• Study design optimization and clinical trial simulations
• Extensive covariate analysis
• Pediatric optimal sampling strategies
• Physiologically based PK/PD modeling
• Exposure, efficacy and safety assessment

Model-Based Trial Design