Services

From drug candidate optimization to Patient Proof of Concept (PoC), PhinC is at your side to design your development and supervise its good execution. Based on Model-Informed Drug Development, we help you increase the confidence in decision making and reduces cycle time of your development.

Below are all our services and fields of expertise:

QT / QTc Analysis (TQT) for cardiac safety

Pioneer in the use of concentration-response modeling approach to document QT-liability through intensive ECG monitoring from first-in-human studies to ICH E14 dedicated TQT study

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Model based drug development

We offer consultancy and operational management services to bridge the gap between therapeutic lead identification to the clinical stage and to the patient PoC.

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Physiologically based Pharmacokinetic

Physiologically Based PharmacoKinetic (PBPK) is a mechanistic approach to predict the absorption, distribution, metabolism and excretion of drugs.

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Modeling & Simulation

Modeling and Simulation (M&S) is a combination of tools to optimize your clinical development. These techniques are used to make the most of the clinical studies data and make best predictions and simulations.

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Pharmacokinetics Statistics

Our pharmacokineticists provide precise analysis of data, whatever the purpose of your pharmacokinetic (PK) studies. We cover all PK analysis requirements.

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Guiding dose selection

Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late‐stage attritions in clinical development.

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Filing for health agencies

PhinC Development provides high-quality, regulatory-compliant PK/PD analyses and modeling for regulatory submission packages.

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Target-Mediated Drug Disposition

Successful development of Biologics requires accurate prediction of human exposure.

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Club Phase 1
GMP - Groupe de Métabolisme et Pharmacocinétique
EUFEMED
AFSSI