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GCP Model Based Analysis: Pharmacokinetic and Pharmacodynamic modeling

PRI uses Phoenix WinNonlin and ADAPT for individual pharmacokinetic and pharmacodynamic modeling work. We use Nonmem version V, version VI, or version VII for population based modeling. We have experience with standard and complex pharmacokinetic evaluations including multiple analytes, enterohepatic recycling models, and multiple peak absorption models (e.g. transit type models and sequential absorption models). PRI has considerable experience with all forms of pharmacodynamic evaluations including direct, indirect, transit models, and effect compartment modeling. We have conducted many PK-QTc evaluations as well. In addition, PRI can conduct exposure adverse event modeling work and time to event and survival modeling. PRI also has experience with disease progression modeling as well!

In addition to the above evaluations, PRI can develop and simulate using adaptive dose strategies for assessing adaptive dosing designs as well as for more robust evaluation of pharmacodynamic models.

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