Overview: The mission of the Preclinical Pharmacokinetics Shared Resource (P-PKSR) is to support and enhance PK and pharmacodynamic (PD) investigations executed in the preclinical setting or in the context of animal models. The P-PKSR is capable of small molecule bioanalyses in multiple matrices (plasma, tissue, organs) using HPLC and LC-MS/MS methodologies. To ensure the highest quality data, assays are typically validated using rigorous criteria derived from P-PKSR standard operating procedures, the FDA Guidance for Industry: Bioanalytical Method Validation, and the 2007 AAPS report on best validation practices.
Impact: Preclinical pharmacokinetic (PK) assessments play a crucial role in the discovery and development processes for new chemical entities and can also be useful in enhancing the clinical use of currently available drugs. When coupled with in vitro or in vivo pharmacodynamic (PD) and tolerability data, preclinical PK can provide the foundation for rationally designed therapeutic regimens. Such regimens have the potential to increase efficacy, reduce toxicity, and accelerate therapeutic development in the clinic. The P-PKSR staff has a combined experience of over 30 years in bioanalytical methodologies and PK/PD analyses, in both academic and industrial drug discovery/development settings.