Pharmacometrics

Bioforum provides Pharmacometrics services to projects from early (animal Phase) to late phase product development (Phase 3). These include Pharmacokinetics (PK), Pharmacodynamics (PD) and disease progression with a focus on populations and variability.  

Our goals:

  1. To optimize the entire drug development process
  2. To increase the probability of success in terms of drug approval
  3. To propose a dosage regimen this will maximize efficacy and minimizing side effects
  4. To reduce costs and unnecessary trials

The Pharmacometrics team works in parallel with multi-disciplinary Bioforum clinical development teams, specifically biostatistics, data management  and medical writing aimed at producing the highest-quality and informative documents.

Services:

  • Writing PK/PD protocols
  • Writing Pharmacometric analysis Plan
    • Goal of the analysis
    • Population PK/PD strategy
  • Performing the Population PK/PD analysis
    • Working heavily with Bioforum database mangement group, the data are formatted, cleaned and QC to enable Population PK/PD analysis
  • Writing Population PK/PD Report
    • Communicating the key findings of the analysis in a language that is understandable to all stakeholders
    • The fully integrated medical writing department works with the Pharmacometric group to provide regulatory proof PK/PD Report