Modeling & Pharmacometrics

Pharmacometrics is the use of mathematical models to describe and characterize the interactions of xenobiotics and a biological system.  Pharmacometrics is accomplished through the use of many tools at Covance, including non-compartmental and compartmental pharmacokinetic analysis, physiologically based pharmacokinetic models (PBPK), integration of pharmacokinetics with pharmacodynamics through PK/PD models, in silico DDI assessment and custom systems pharmacology models. 

Computational & In Silico Pharmacometrics

Pharmacometrics can help to better predict pharmacokinetics (PK), drug response (PD) and drug-drug interactions (DDIs). The ability to predict these aspects of your molecule in development can help you to develop a streamlined program to enable moving quickly from discovery to development.

In addition, it can also help you build better and more efficient study designs to save time and money.  We can help you in the exploration of how pharmacometrics can lead you to the next stage of your drug development program as well as implement the tools necessary to bring you the results that you need.

Computational modeling & pharmacometrics

A compartmental PK model is generally more complex than a noncompartmental PK model and allows for prediction of modeling profiles between compartments when experimental parameters are altered. Compartmental PK is appropriate for large and small molecules. 

PK / PD modeling creates one set of mathemtical expressions for PK & PD disciplines in order to better understand how a molecule's dose intensity varies over time. As such, PK / PD modeling allows you to better assess ADME properties, establish safety margins and assess dosage change requirements. PK / PD  modeling is often used for compartmental PK studies as well as population PK studies. 

PBPK modeling in being accepted more commonly by regulatory agencies as a way to inform clinical study designs and is also used as a way to compare therapeutic indications from multiple drug candidates. PBPK modeling does require a set of in vitro and in vivo data to verify the models. 

Quantiative and/or Systems Pharmacology (QSP/SP) modeling, a subdiscipline of pharmacokinetics, is an approach that integrates preclinical mechanistic evidence and physiological system models to investigate and predict drug response. 

 

WEBINAR RECORDING

PBPK modeling to support clinical DDI studies

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POSTER

PBPK modeling for optimization of sustained-release orthodontic retainer of Clonidineto

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WEBINAR RECORDING

Understanding FDA regulations & applying in vitro & PBPK modeling techniques

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