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 provided by the Investigational Chemotherapy Service:
For ICS services, please contact Beth McClendon Arvik at 919.668.0657.
Services provided by the PK/PD Service:
For PK/PD services, please call Ivan Spasojevic, PhD, at 919.684.8311.
The Investigational Chemotherapy Service's major equipment includes:
The PK/PD Core's major equipment includes:
DCI members have priority access and reduced pricing.
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.
Pharmacokinetics & Investigational Chemotherapy
Putting a new cancer medication through the early stages of clinical trials is an intimidatingly complex process. A proper dosage regimen must be tailored for every patient. Medications may need to be mixed into a solution at a specific ratio, kept at certain temperature until just before use, or prepared according to other instructions, while meeting FDA and Cancer Therapy Evaluation Program guidelines. Medications may be given orally, through an IV line, subcutaneously, or through other means. More
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