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.

hand holding something above a vial
Biorepository Overview

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.

icon

The Preclinical Pharmacokinetics core helped us to design novel drug treatment studies in our model systems using agents known to have some effects in patients. This type of resource is not available or accessible to translational investigators in many other places.

Esther Obeng, Assistant Member


Equipment and Capabilities

  • Highly sensitive and specific analytical equipment, providing very low limits of quantitation (0.1-10 ng/mL) from small volume samples with notable precision and accuracy
    • SCIEX API 4000 LC-MS/MS system
    • SCIEX Q-TRAP 5500 LC-MS/MS system with PAL HTS-xt autosampler
    • Two (2) SCIEX Triple Quad 3500 LC-MS/MS systems
    • Shimadzu 20 series HPLC system, with autosampler and UV/PDA detector
    • Mettler-Toledo XP-26 microbalance (dynamic range: 1 μg – 22 g)
  • Advanced sample processing and preparation
    • Labconco CentriVap vacuum assisted evaporator
    • MP Biomedicals FastPrep-24 small volume tissue homogenizer
  • Secure, short term sample storage
  • Various software packages for sophisticated data analysis and model fitting

By the numbers: 

25+

peer-reviewed publication contributions

94

PK-related projects since 2011

20+

PI partnerships

 

14

Average impact factor of publications

Director

Burgess Freeman

Burgess B. Freeman III, PharmD

Director, P-PKSR
burgess.freeman@stjude.org