Pharmacokinetics & Investigational Chemotherapy

Program Leadership

Paul Bush, PharmD, MBA, FASHP, BCPS
Co-Director
Paul Bush, PharmD, MBA, FASHP, BCPS
919.681.2755 Email
Ivan Spasojevic, PhD
Co-Director

Overview

The primary purpose of the Pharmacokinetics & Investigational Chemotherapy Shared Resource is to provide a broad spectrum of pharmacological and pharmaceutical services essential to the conduct of preclinical and clinical research in oncology, drug discovery, drug evaluation, and related areas by members of the Duke Cancer Institute (DCI). It is composed of two services: the Investigational Chemotherapy Service and the Pharmacokinetics/Pharmacodynamics (PK/PD) service.

The Investigational Chemotherapy Service (ICS) is available to all DCI investigators for the purpose of preparing investigational drug products, maintaining drug accountability records and investigational drug inventories according to FDA and Cancer Therapy Evaluation Program (CTEP) guidelines. In addition, this service provides design consultation, professional staff education, and implementation services for clinical research studies. The ICS is managed by the Department of Pharmacy under the leadership of Paul Bush, PharmD, Chief Pharmacy Officer. Beth McLendon-Arvik, PharmD is the Manager of Duke University Hospital Investigational Drug Services and the ICS. The ICS is staffed by a clinical pharmacist, a clinical research coordinator and clinical research specialist. The ICS utilizes a software program, Vestigo, to automate and streamline many aspects of its daily workflow.

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 Investigational Chemotherapy Service:

  • Major Services 
    • Investigational drug product preparations and maintaining drug accountability records and investigational drug inventories
    • Consultation regarding research study design
    • Implementation of new research studies and conducting professional staff education regarding investigational drug studies
    • Pharmacy review of protocols for Cancer Protocol Review Committee and Institutional Review Board
  • Protocol Specific Services include 
    • Preparing online pharmacy procedures/drug data sheet
    • Creating the medication orderable build in Epic EHR and collaborating with study team to create the study protocol template. Randomization, secure storage, accountability, blinding, preparation/compounding, patient counseling, staff education, records management
    • Audits (CDQA, Sponsor), Inspections (FDA)
    • Ensure adherence to USP <797> standards

For ICS services, please contact Beth McClendon Arvik at 919.668.0657.

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 Investigational Chemotherapy Service's major equipment includes:

  • Investigation drug research software - Vestigo
  • Six refrigerators (4 degree C)
  • Three freezers (-20 degrees C)
  • Fume hood for oral study preparation
  • Dedicated clean room for gene therapy preparation
  • Investigation Chemotherapy Pharmacy Facility (room 4N33) co-located with the Cancer Center Infusion Pharmacy (room 4N31)

The PK/PD Core's major equipment includes:

  • Applied Biosystems/SCIEX API 5500 QTrap + Agilent 1200 series LC (2008)
  • Applied Biosystems/SCIEX API 4000 QTrap + Shimadzu 20A series LC (2008)
  • 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 Investigational Chemotherapy Service's primary location is in the new ambulatory Duke Cancer Center building (room 4N33), with additional preparation and dispensing sites located in the Duke Hospital Pharmacy, the Duke Children's Health Center Pharmacy, and the Duke North Pavilion (Bone Marrow Transplant) Pharmacy.

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.