The Analytical Pharmacology Core is equipped with the latest instruments and software necessary in support of preclinical investigations and Phase I or Phase II clinical trials of new drugs, imaging agents, and chemical compounds. The Analytical Pharmacology Group routinely works with complex bioanalytical test procedures and pharmacokinetic analyses to help investigators at the basic and clinical levels. The laboratory staff and scientists are skilled in method development and validation for analysis of drugs and metabolites in biological matrices, for example plasma, using advanced and sensitive techniques. While this core is available for all investigators at the Center, the investigators and the management of the core facilities will evaluate the feasibility before a planned study is initiated. We can conduct these analyses under Good Laboratory Practise (GLP) guidelines as needed.
Instrumentation
Available capabilities include chromatography (HPLC), spectroscopy (UV, FL), and electrophoresis as well as LC/MS/MS. Our LC-MS/MS facilities include a 96-well plate autosampler (Shimadzu) and a triple quad LC-MS/MS from Applied Biosystems (MDS Sciex API 4000) with ES and APCI ionization. The API 4000™ LC/MS/MS System is an enhanced high-performance triple quadrupole mass spectrometer system with applications in protein and peptide analysis, small molecule analysis in drug metabolism and pharmacokinetic studies, and n-in-one cassette dosing analysis. System includes Turbo V™ Source, TurboIonSpray® probe, APCI probe, Analyst® software, and Data Acquisition Station. Automated liquid-handling systems are also available to increase the throughput of the analyses. The Biomek 2000 Laboratory Automation Workstation in series with Biomek NX meets the demands of rapidly changing life science technology with simple, intelligent automation of liquid-handling tasks. Pipetting, diluting, and dispensing operations are performed quickly, easily, and automatically. The modular platform allows expansion of system capability to include plate heating and cooling, plate washing, high-density transfers, photometric measurement, and high-capacity operation. This fully automated system uses 96-well or 384-well plate formats. The entire system is controlled by Biomek software with an intuitive graphical interface.
Pharmacokinetics
The facility also provides services for nonclinical and clinical pharmacokinetic (PK) analyses in support of pharmaceutical development or toxicity studies. In-house test procedures and templates (Table 1) for pharmacokinetic analysis and reporting have been developed to obtain high-quality results with the data-analysis descriptions in the Study Protocol and/or other agreements made with the investigators. Clinical pharmacokinetic analysis and reporting is performed according to GLP principles.
Table 1 -- Partial List of In-house Test Procedures
