Comprehensive pharmacometrics and clinical pharmacology solutions
It has never been more important to consider utilizing model-based strategies as part of your drug development program. Our MIDD services leverage cutting-edge AI and traditional pharmacometric approaches to accelerate your path to regulatory approval.
Establishing the appropriate dosing regimens is critical to maximizing safety and efficacy for patients and clinical trial participants. Our pharmacologists and pharmacometricians are experts in dose translation, selection, and justification across all therapeutic areas, modalities, and stages of development.
Utilizing Modeling & Simulation, including the Bayesian approach, proves invaluable in guiding dose selection. Our prowess in this arena is exemplified by the impressive capabilities of DrLevy.AI and our proprietary PHIKL software.
When planning your pediatric development or 505(b)(2) development program, you must determine how to support the efficacy and safety. You can leverage existing knowledge to bridge efficacy and safety to the new population or new product or new dosing regimen.
We specialize in the nuanced science of extrapolating pediatric efficacy and bridging studies, helping you navigate complex regulatory pathways with confidence.
Using modeling and simulation, existing data can be leveraged to provide critical insights on product safety and effectiveness as related to drug concentration. They can guide trial design, provide evidence of effectiveness and support labeling.
Our AI-powered modeling approaches, combined with traditional pharmacometric methods, enable more efficient trial designs and faster decision-making throughout the drug development lifecycle.
Develop innovative platforms like DrLevy.AI that integrate AI technology with industry-standard pharmacometric tools
Expert consulting services for PK/PD modeling, population pharmacokinetics, and quantitative systems pharmacology
Build proprietary software solutions including PHIKL and other specialized tools for pharmacometric analysis
Advanced data analysis, NONMEM execution, and sophisticated modeling services for pharmaceutical research
Partner with academic institutions and pharmaceutical companies to advance pharmacometric research
Provide training programs and educational resources for pharmacometricians and clinical pharmacologists
Advanced modeling techniques for understanding drug behavior in populations
Integrated modeling approaches linking drug exposure to clinical outcomes
Systems-level modeling for comprehensive drug mechanism understanding
Expertise in NONMEM, R, and proprietary software development
Application of AI and ML techniques to pharmacometric challenges
Support for regulatory submissions and clinical trial design
Contact us to discuss how we can help with your pharmacometrics needs