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Dose Exposure/Response & Clinical Trial Simulations

One of the major purposes of a clinical trial is to determine the appropriate dose of the drug candidate required to achieve the desired pharmacological effect. Thanks to statistical and pharmacometric methods PhinC can assess those data.

Pharmacological Activity Assessment

If your objective is to bring your drug candidate plasma concentration within the therapeutic framework, use modern statistical and pharmacometric techniques to do so efficiently.

Our master techniques for quantitative modeling to evaluate different dose parameters include exposure/response, activity/response and occupancy/response. They optimize the dose in order to reach the desired pharmacological effect.

When performing a model-based assessment of PK/PD, our pharmacometricians will determine the dosing route (oral, intramuscular, intravenous, etc.), the dose regimen and the length of treatment.

Those assessments can be performed regardless of the target population - patients with multi-pathology or specific nutritional requirements, children, elderly people, etc.

Clinical Trial Simulations (CTS)

In order to advance with the method, PhinC can proceed to performing Clinical Trial Simulations (CTS). Indeed, the pharmacological activity assessment and CTS are both linked by the need for strong PK/PD, PK/efficacy or PK/safety markers.

Population PK/PD models are used to simulate a clinical trial, which can influence the impact of study designs on trial outcomes. Using this method, various “what if” scenarios can be tested several times for confidence in designing future trials. CTS can contribute to a reduction in the overall costs of drug development.