Pharmacodynamics is the assessment of effect of a product on the body measured as safety or efficacy endpoints. PK/PD modeling relates the observed effect to the concentration of product in systemic circulation.
Our methodology typically includes:
- Pharmacodynamic analyses using various graphical and statistical approaches PK/PD non-linear and non-linear mixed modelling techniques
- Simulation
Assessment of PD and PK/PD are applicable in support of pharmacology studies as well as the clinical setting.
Industry standard software used within our Pharmacokinetics and PK/PD Modelling Group include SAS (SAS Institute, Inc.) and WinNonlin Pro (Pharsight Corporation). These applications are validated in accordance with our Computer System Validation procedures and meet the requirements stipulated by regulatory bodies. Validation documentation is available for review on-site.