University of Southern California
USC Norris Comprehensive Cancer Center

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If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

PharmacoAnalytical Core Facility

Welcome to the USC Norris Comprehensive Cancer Center PharmacoAnalytical Core Facility.  The Facility was established to serve the USC community, more specifically clinicians and scientist who are interested in translational science. 

Drug development from the laboratory to the patient goes through various processes and testing.  This includes preclinical drug development to clinical trials ranging from Phase I to III that ultimately lead to Food and Drug Administration or FDA approval for widespread patient use.  This process begins with precise knowledge of drug disposition and pharmacokinetic properties, such as drug absorption, distribution, metabolism and elimination.  These properties are critical factors that may determine successful clinical outcomes and the onset of drug-related toxicities. 

Using precise and sensitive instrumentation, the USC Norris Core Analytical Laboratory develops, validates and performs qualitative and quantitative drug assays and their metabolites in various biological matrices.  In addition, the analytical laboratory is developing insights to factors that may influence drug absorption, distribution, and metabolism, which may lead to improved clinical outcomes.  This can translate into elimination of the cancer while minimizing the adverse effects that has been associated with cancer therapy.  Other supportive roles of this laboratory include developing insights into potential pharmacological interaction(s) between the various components of a chemotherapeutic regimen. 

The laboratory provides analytical support for drugs in Phase I to IV clinical trials.  In Phase I clinical trials this laboratory provides analytic support to determine the various pharmacokinetic parameters such as maximum tolerated dose (MTD) in drug dose ranging studies.  The capability of the laboratory to identify and determine drug-metabolite and their concentrations present is particularly important to evaluate potential of drug-drug interactions that may affect the drug disposition of one or more of the agents.  The laboratory is an important resource in providing both analytical and strategic capability to monitor therapeutic drug levels and correlate clinical and pharmacodynamics outcomes.  Other activity of this laboratory includes population modeling, which will allow smaller patient sampling to have farther reaching conclusions. 

The USC Norris Core Analytic Laboratory provides modern, sophisticated qualitative and quantitative analytic capability including high performance liquid chromatography (HPLC) using conventional UV/visible and fluorescence detection.  In addition, this laboratory has the capability to perform drug assays that require liquid chromatography with mass spectrometry detection to measure drug activity not only in the blood but also intracellularly.  This capability is crucial because it can lead to the development of more specific drugs leading which increase antitumor activity while reducing drug related toxicities. 

The laboratory can provide drug level-time data analysis and pharmacokinetic model development for the determination of pharmacokinetic parameters for optimizing drug dosing regimens.  The laboratory can assist in the design of clinical protocols that may impact the pharmacokinetic components in a particular study.  This may include protocol develop in terms of appropriate specimen collection methods, timing of sampling strategy, specimen preparation, handling and storage.

The laboratory is currently undergoing one of the most extensive upgrading of existing instrumentation in the last 15 years.  This will include the addition of new HPLC system that will provide more reliable and sensitive detection while reducing the quantity of samples required to perform the assay.  In addition, this laboratory will be anticipated the addition of a liquid chromatograph mass spectrometry (LC-MS) [Applied Bioscience API III+], which will not only improve sensitivity, but enhance capability to perform intracellular drug concentrations, and develop methods for proteomic determination.  This is a quantum leap to determine whether drug concentration at the desire site will correlate factors that will impact pharmacodynamics and clinical outcomes.  This tool will permit the development of individualized dosing.  More importantly, this laboratory will venture into determining the relationship of genotyping and clinical response to various anticancer agents.