DF/HCC Clinical Pharmacology Core
The Clinical Pharmacology Core provides DF/HCC investigators with the necessary expertise and resources to design and undertake pharmacokinetic studies in phase I and phase II clinical trials and preclinical investigations. The Core can implement and validate established analytical methods to quantify drugs and their metabolites in biological fluids; it can also modify or develop entirely new assays when necessary.
Director: Jeffrey Supko, Ph.D.
Phone: (617) 724-1970
Fax: (617) 726-6974
Research Associate: Xiaoying He, Ph.D.
Phone: (617) 726-5854
Research Associate: Olga Tretyakov, M.D.
Phone: (617) 632-5625
Fax: (617) 632-2933
Location of Core:
The facility is located at 32 Fruit Street, Jackson Building, 10th Floor, Boston.
►Experimental design and protocol development
►Preparation of dosing and sample collection case report forms and sample labels
►Establishing and implementing appropriate procedures for sample handling, processing,
and storage prior to analysis
►Sample storage and tracking
►The development, validation, and application of analytical methods to measure drugs and
their metabolites in biological fluids
►PK data analysis and interpretation
►Correlation analyses to assess the influence of pathophysiologic variables on PK parameters
and associations between PK parameters and biological effects such as toxicity, biological
correlates, and therapeutic response
►Assistance in the preparation of manuscripts and presentations<!--EndFragment-->
It is not feasible to develop a predetermined cost schedule for the services offered by the Core because of the highly specialized and varied nature of bioanalytical methods. The integrated collection of procedures that comprise an analytical method, which include sample storage, preliminary sample preparation, chromatographic analysis, and detection depend upon the unique physicochemical characteristics of the particular drug of interest, the sample matrix, and nature of the application. Costs for the analysis of samples depend upon whether the particular assay has already been established within the facility, whether suitable assays for a drug have been described in the literature, or whether an entirely new assay will need to be developed. The complexity of the sample preparation and detection methods used in an assay also significantly impact costs. Costs for assay development are largely dependent upon the physicochemical properties of the compound, as well as its potency, which generally dictates the sensitivity required to adequately detect systemic levels of drug afforded by tolerated doses.
Accordingly, the costs for bioanalytical services must be developed individually for each project.
To access the core, please contact Jeffrey Supko at (617) 724-1970 or by email at
Departmental Web Link: