Safety, Pharmacokinetics & Pharmacodynamics

Functional Safety

PBI conducts PK, PD and safety experiments in mechanistically relevant disease settings. PBI provides robust safety pharmacology services by performing direct organ functional measurements and in-house biomarker analysis. We offer our clients:

  • Real-time evaluation of direct hemodynamic and cardiac output in response to the administration of escalating levels of compound;
  • Steady-state renal glomerular filtration rate (GFR) and blood flow (RBF) evaluation with concurrent measurement of renal toxicity urinary biomarkers, such as KIM-1 and NGAL;
  • Non-invasive and invasive pulmonary mechanics in response to acute compound administration.

Pharmacokinetics In Compromised Animals

Pharmacokinetic alterations become prevalent when animals have reduced organ function, resulting in unintended systemic compound exposure and elevated presentation of side effects. Conducting the in-life phase of a PK study in compromised animals provides data that is reliable and predictive of how the compound will act in a disease setting.

Mechanistically Relevant Pharmacodynamics

PBI’s collective years of pharmaceutical discovery and development in the cardiovascular, renal, hepatic and pulmonary disease areas can help guide PD experiments to the best model for target engagement. In conjunction with reliable biomarkers, acute PD models can be run as functional screens to give the breadth and efficiency necessary for our clients’ drug discovery efforts.