Overview

Pharmacokinetics and Pharmacodynamics Shared Resource Core is available to all DCI investigators for pharmacokinetics, pharmacodynamics, and small molecule research. It is staffed by research analysts and is equipped with state-of-the-art analytical and computational equipment. It provides expertise in clinical and preclinical PK/PD, the drug development process in general, as well as in the analysis of low molecular weight metabolites and biomarkers for basic research.

Services

• ASSAY development and validation (HPLC, LC-MS/MS) for quantitative analysis of drugs, drug metabolites, and biomarkers in cell culture, biological fluids, and tissues
• PRECLINICAL PK/PD support: 
  • ACUC protocol approval (mouse and rat)
  • Dosing formulation development and strength and stability assessment (HPLC)
  • Drug administration (IV, PO, IP, SQ, IT)
  • Collection of blood/plasma/urine/feces and tissue/organs (serial vs euthanasia at time-point)
  • Drug/ drug metabolite analysis in plasma and tissues, PK modeling
  • Tumor PK/PD studies (xenograft implantation, tumor size measurement, drug analysis
• CLINICAL PK/PD support (Phase I/II):
  • Study design (blood/plasma collection protocol, time-points)
  • Logistical assistance (sample transport, processing, and storage)
  • Drug/drug metabolite(s) analysis in plasma/tissue biopsies
  • PK modeling and results reporting to FDA
  • PK/PD MODELING, compartmental/non-compartmental (WinNonlin, SAAM II + PopKinetics); dosing regimen design for subsequent efficacy studies
  • In-vitro ADMET assays for drug-like properties and early safety assessment of drug candidates (in-house and out-sourced)
  • Assistance in data interpretation, publishing, grant applications

Equipment

• Liquid Chromatography – Tandem-Mass Spectrometers (LC/MS/MS):
  • Applied Biosystems/SCIEX API 5500 QTrap + Agilent 1200 series LC
  • Applied Biosystems/SCIEX API 4000 QTrap + Shimadzu 20A series LC
• Conventional HPLC: Waters 2695 and Shimadzu 20A series stacks with fluorescence and uv/vis detectors
• Sample processing equipment (homogenizers, evaporators/concentrators, SPE, centrifuges)
• Nanoparticle sizer/zeta potential: Nano-Brook 90Plus PALS (Brookhaven Instruments)
• Plate reader SPECTRA-Max 250 (Molecular Devices) with SoftMAX Pro software
• Rodent anesthesia/surgery station (breathing/anesthesia machine, stereo microscope)
• Metabolic cages for controlled feeding and urine/feces collection