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.
- To optimize the entire drug development process
- To increase the probability of success in terms of drug approval
- To propose a dosage regimen this will maximize efficacy and minimizing side effects
- 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.
- 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