During FY07, the Clinical Pharmacology Program (CPP) provided support to over 40 clinical trials. This support ranged from sample pickup and processing, to full analytical method development and validation, pharmacokinetic and pharmacogenetic analysis and assistance with trial design. In FY07, the CPP received over 14,000 biological samples including blood, urine and saliva. Upon arrival, all samples are processed, barcoded and frozen for future use. The first priority in characterizing the pharmacokinetics of an anticancer agent is to develop a reliable and reproducible analytical method for quantitating agents in biological fluids and tissues. The CPP utilizes high performance liquid chromatograpy (HPLC) coupled with state-of-the-art detection instruments including mass spectrometers, tandem mass spectrometers (MS/MS) and diode array detectors (for UV absorption) to measure drug concentrations. Following method development, assays are validated according to the FDA Guidelines for Bioanalytical Method Development. The CPP is currently focused on the method development, validation and subsequent human sample analysis for sorafenib, finasteride, docetaxel and multiple formulations of paclitaxel (including ABI-007). The group has recently validated and published an assay for 17-DMAG, and sample analysis is ongoing in support of a Phase I clinical trial being conducted within the CCR. The CPP has previously developed analytical methods for a wide range of other therapeutics, including depsipeptide, TNP-470, phenylacetate, phenylbutyrate, tamoxifen, UCN-01, CAI, thalidomide, COL-3, suramin, melphalan, erlotinib, perifosine, SU5416, 2ME, MS-275, ketoconazole and CC5013.
Showing the most recent 10 out of 11 publications
