You are here: Home Services Pharmacometrics and PK statistics Translation from Non-Clinical to Human Studies

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.

Using M&S in Early Drug Development

Cube Modeling & Simulation

One major reason for the high cost of drug development is the many unnecessary studies, where the results could have been predicted with reasonable certainty. In vivo experimentation does not have all the answers. In this context, Modeling & Simulation is a powerful alternative approach. These approaches are generally used in later clinical stages. At PhinC Development, we use these methods in early preclinical phases. This approach allows for overall integrated drug development.

Increasing Rapidity

PhinC builds initial predictions based on the known properties data for the drug candidate or results from typical high-throughput screening. We then develop interspecies predictions using an iterative approach:

  • The PBPK model is constructed based on experimental data (characteristics of the molecule, in vitro, in vivo),
  • The model is then adjusted at each stage of preclinical development through comparison with experimental results,
  • The pattern is optimized for the following studies,
  • The data generated are used as a basis for justifying a first dose in a human study.

Our team, composed of scientists with additional knowledge, is fully trained to develop useful and creative PopPK and PK/PD models, and has a thorough knowledge of the internationally recognized software packages NONMEM, SAS, Monolix and GastroPlus.