During FY15, the Clinical Pharmacology Program (CPP) provided support to over 80 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 FY15, the CPP processed over 30,000 biological samples including blood, urine and ascites. 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 chromatography (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 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, lenalidomide, romidepsin, AZD2281 and gemicitabine, sorafenib, finasteride, nelfinavir, 17-DMAG, clopidogrel and and its MPB-derivatized active thiol-metabolite (CAMD), Hsp90 inhibitor PF-04928473, irinotecan (its active metabolite SN38, and glucuronidated SN38), NSC-726796, Trk kinase inhibitor AZD7451, pomalidomide, and olaparib. We have recently developed a UPLC-MS/MS method for quantitation of mithramycin in human plasma in patients enrolled on two clinical trials at the NCI. The CPP is currently focused on the method development, validation and subsequent human sample analyses for vandetanib, metformin, 5-Azacytidine, cediranib, alisertib, Barasertib, SCH-1473759, and XZ446.