Our Services
Our guarantee to clients:
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To provide high quality pharmacometrics services catered to your needs.
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To collaborate and actively engage with you every step of the way.
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To share our knowledge base that has an accumulated 55+ years of experience in the field of quantitative clinical pharmacology.
Our services include:
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Population PK and PK-PD analysis
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Exposure-response analysis
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Model-based meta-analysis
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Dose or regimen selection
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Regulatory filing support
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Strategic guidance from translational to post-marketing settings
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Clinical pharmacology support
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Mentoring and training
PK/PD Modeling
and Simulation
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Population pharmacokinetics (PopPK) modeling
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Longitudinal pharmacokinetic/ pharmacodynamic (PK/PD) models
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Translational modeling
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Exposure-response modeling
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Integrated efficacy-safety analysis
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Bridging between populations (e.g., by region, race, and disease)
Analysis results may be applied to support first-in-human dose selection, clinical study design, and dose regimen optimization
Model-Based
Meta-Analysis
A methodology that leverages data from a variety of sources, both proprietary and public, to support drug development decisions including dose selection and product positioning. Analyses include bridging efficacy and safety data between a new chemical entity and an established drug class, bridging between indications, linking biomarker data to clinical outcomes and characterizing dose-response relationships
Drug Development Strategy Consult
Strategic guidance services from translational to post-marketing settings, including support for regulatory submissions.
Mentoring and Training
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Programs focused on select aspects of quantitative clinical pharmacology methodology tailored to an individual or a group
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Guidance or support on a project and regulatory filing activity
What is quantitative clinical pharmacology (QCP)?
QCP is the approach of using quantitative modeling to better understand, and hopefully explain, the relationship between the drug and its pharmacokinetic and pharmacodynamic properties.
Why is it important?
We translate findings from our quantitative models to guide a safe and effective dose selection. Without an accurate model, the dose selection can result in unforeseen toxicities or lack of efficacy. In fact, almost 16% of new drug applications fail because of uncertainty around the appropriate dose[1]. We would like to collaborate with our clients and try our best to ensure they are not part of the 16%.
[1] Sacks, L.V., Shamsuddin, H.H., & Yasinskaya, Y.I. (2014). Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA, 311(4), 378-384. DOI: 10.1001/jama.2013.282542
