- DF/HCC Pharmacokinetics and Bioanalytical Chemistry Core
DF/HCC Pharmacokinetics and Bioanalytical Chemistry Core
The DF/HCC Pharmacokinetics and Bioanalytical Chemistry Core (previously the DF/HCC Clinical Pharmacology Core) offers the expertise and laboratory capabilities required to undertake preclinical and clinical pharmacokinetic (PK) studies. Undertaking a PK study necessarily depends upon the ability to accurately and precisely measure the test drug in biological fluids and tissues. The physical facilities of the Core are a bioanalytical chemistry laboratory with dedicated instrumentation and technical staff. High performance liquid chromatography with tandem mass spectrometric detection (LC-MS/MS) is well established as the technique of choice for the quantitative analysis of low molecular weight drugs in biological fluids. The Core has invested heavily in this methodology and presently has three LC-MS/MS systems. It also has HPLC systems with conventional detectors and a microtiter plate reader for ELISA and biochemical assays. The Core can readily establish and appropriately validate bioanalytical methods that have been developed in other laboratories as well as the de novo development of assays for newly discovered molecules. Every bioanalytical method established by the Core is appropriately validated and applied to the analysis of samples from PK studies as recommended by the current FDA Guidance for Industry.
Personnel/Contact Information:
MGH
Director: Jeffrey Supko, Ph.D.
Phone: (617) 724-1970
Email: jsupko@partners.org
Other Staff:
Research Associate: Xiaoying He, Ph.D.
Phone: (617) 726-5854
Email: xhe@partners.org
Facilities:
Location of Core:
The facility is located at Massachusetts General Hospital, 55 Fruit Street, Room GRJ1025, Boston, MA 02114.
Services:
► Experimental design of nonclinical and clinical PK studies
► Procedures for sample collection, processing, and storage
► Assay development and validation
► Routine analysis of study samples
► Metabolite identification
► Comprehensive PK data analysis
► Evaluate PK - PD (pharmacodynamic) relationships
► Develop drug formulations for nonclinical PK studies
► Assistance with presentations and manuscripts
Fee Schedule/Rates:
The Core is a fee for service facility that can be used by DF/HCC members, investigators at MGH and other HMS institutions, external academic centers, and private pharmaceutical companies. A formal contractual agreement is not required for the Core to provide services to entities external to MGH and the DF/HCC. Fees for all services offered by the Core, as listed below for FY21, are based upon a detailed analysis of operational expenses and utilization of services subject to review and approval by the Mass General Brigham Research Core Facilities Office annually.
Service |
Fee (direct cost) |
Assay development/validation: Enzymatic or ELISA (cost unit, 1 day) |
$350.00 |
Assay development/validation: HPLC (cost unit, 1 day) |
$350.00 |
Assay development/validation: LC-MS/MS (cost unit, 1 day) |
$600.00 |
Study sample analysis: Enzymatic or ELISA (cost unit, 1 sample) |
$50.00 |
Study sample analysis: HPLC, standard (cost unit, 1 sample) |
$50.00 |
Study sample analysis: HPLC, complex (cost unit, 1 sample) |
$75.00 |
Study sample analysis: LC-MS/MS, standard (cost unit, 1 sample) |
$100.00 |
Study sample analysis: LC-MS/MS, complex (cost unit, 1 sample) |
$125.00 |
PK data analysis (cost unit, 1 data set) |
$100.00 |
Project reports (cost unit, 1 day) |
$250.00 |
Study sample storage/management (cost unit, 1 month) |
$100.00 |
Packaging and handling for shipment (cost unit, 1 sample) |
$2.00 |
Getting Started:
To access the core, please contact Jeffrey Supko at (617) 724-1970 or by email at
Departmental Web Link:
https://www.dfhcc.harvard.edu/research/core-facilities/pharmacokinetics-and-bioanalytical-chemistry/
