Semler Research - Pharmacokinetics & Statistics

We conduct comprehensive Pharmacokinetic / Pharmacodynamic (PK/PD) and statistical data analysis using the industry standard. SRC uses WinNonlin Version 5.0.1 for noncompartmental estimations of pharmacokinetic and pharmacodynamic data. The installation of the software has been qualified and validated.

Benefits of WinNonlin Version 5.0.1

- It is the easiest and one of the most user friendly pharmacokinetics data analysis software available.
- Its Excel-based program provides wide flexibility in a familiar spreadsheet environment.
- Provides graphs and tables of the most widely used pharmacokinetic parameters.
- Helps you analyze, record, compare, and report pharmacokinetic and ADME study results.

The pharmacokinetics team is involved in the following activities

- Provide inputs to pharmacokinetic sections of the study design and clinical study protocol
- Development of PK/PD datasets to meet analysis requirements.
- Non-compartmental pharmacokinetics
- Preparation of pharmacokinetic sections of the clinical study reports and illustration with graphs, tables and charts.

SRC has expertise in both clinical and nonclinical non-compartmental analysis and reporting. Our Pharmacokineticists work closely with our statistical, scientific writing, and bioanalytical staff at all stages of the study from study initiation to study completion and reporting to ensure a smooth and effective transition of high-quality Pharmacokinetic data from our bio analytical laboratory to the Pharmacokinetics department and then to our statistical and medical writing groups and finally in the preparation of comprehensive ICH compliant reports.