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Model-Based Drug Development (MBDD)

Model-Based Drug Development : clinical development piloted totally or in part by results coming from models of quantitative pharmacology.

PhinC offering in the area includes:

QT/QTc analysis (TQT) for cardiac safety

PhinC helps you to take charge of and limit any additional costs during the QT process. We take measures in the ECG data analysis and study design phases, using pharmacometric and statistical tools.

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Development Plan Design and Optimization

After diagnosing your situation, PhinC offers you the most suitable development plan. Furthermore, we aim to optimize it using Model-Based Drug Development.

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Translation from Non-Clinical to Human Studies

Using innovative approaches, including PK/PD modeling, PopPK models, and PBPK models, PhinC can help you to progress from preclinical studies to first-in-man studies, rapidly and efficiently.

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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.

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Sampling and Sample Size Strategies

Optimal sampling (number and timing of samples) and sample size (number of patients) are strategic calculations to perform and establish in order to reach study objectives through efficient study design. PhinC can assist you in these important stages of clinical development.

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