ServicesClinical PK/PD

Service Overview

 

We can offer Model Based Drug Development (MBDD) services which include:

Arrow Population PKPD analysis of clinical data – select the right dose and regimen to maximise efficacy and minimise safety concerns

Arrow Back-translational analysis – place emerging early clinical data within the context of the pre-clinical data package

Arrow Optimal design of future studies – minimise no. of measurements to maximise information

Arrow Preparation for due diligence – merge preclinical and clinical data to provide a holistic view of the compound, including meta-analysis of the competition

 

Model Based Drug Development Benefits

 

efficacy_pk_s
Fig. 1 Visual predictive check plot for a 2 compartment PK model (left panel) and predicted probability of response as a function steady-state Cmin (right panel).

Physiomics have experience in analysing early clinical data (Phase 1 and 2) within oncology with specific expertise in relating plasma markers to hard clinical endpoints. We can address project questions such as:

  • MTD > therapeutic dose
  • Optimal dose/regimen to take forward
  • Formulation/regimen deliver the required exposure profile
  • Biomarker response confirm preclinical findings
  • “Targeted” population identified
  • Dose selection supported
  • Proof of Concept confirmed