Pharmacokinetics & Pharmacodynamics Shared Resource
Overview
The PK/PD Core is available to all DCI investigators for pharmacokinetics, pharmacodynamics, and small molecule research in general providing the following services: study feasibility assessment and design of Phase I/II clinical studies and comprehensive pre-preclinical PK/PD studies for candidate drugs, analytical assay development and analysis of drugs and metabolites in bodily fluids and tissues, PK/PD modeling, data interpretation, publishing, and help with funding applications. The facility is managed by DCI under the leadership of Ivan Spasojevic, PhD, an Assistant Professor in the Department of Medicine. It is staffed by research analysts and is equipped with state-of-the-art analytical and computational equipment.
Services
Services provided by the PK/PD Service:
- Major Services
- Targeted Quantitative Analysis of drugs, drug metabolites, and biomarkers
- Using liquid chromatographs coupled to triple quadrupole mass spectrometry
- Using liquid chromatographs coupled to fluorescence and uv/vis detectors
- Using ELISA assays on fluorescence and uv/vis plate readers
- Comprehensive PK/PD service
- Phase I/II clinical PK/PD study design and assistance (blood/plasma collection protocol, time-points)
- Preclinical PK/PD experiment (animal DLAR protocol, drug administration, sample collection/storage)
- Drug/metabolite assay development (LC-MS/MS, HPLC, ELISA)
- Compartmental/non-compartmental modelling (WinNonlin, SAAM II + PopKinetics)
- Assistance in data interpretation, publishing, funding applications
- On-site consultation for collaborative creation of custom experimental designs
For PK/PD services, please call Ivan Spasojevic, PhD, at 919.684.8311.
Equipment
The PK/PD Core's major equipment includes:
- Conventional 2695 HPLC (Waters)
- Waters 2475 scanning fluorescence detector
- Waters 2487 dual wavelength uv/vis detector
- Plate reader SPECTRAmax 250 (Molecular Devices) with SoftMAX Pro software
- Pharmacokinetics software
- Win Nonlin
- SAAM II v2.3 + PopKinetics
- Two refrigerators (4° C)
- Two low temp. freezers (-20° C)
- Three ultra-low temp. freezers (-80° C)
- Two biohazard hoods
Fees
DCI members have priority access and reduced pricing.
Locations
The PK/PD Service is located in the Duke Clinics Building (Orange Zone, room 5317), which is contiguous with the new Duke Cancer Center building.