DCTD Phase I/II CT PK/PD Studies

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SAIC-Frederick provides technical and material support of laboratory correlate studies in the areas of pharmacokinetics and pharmacodynamics (PK/PD) for the Phase I and II early clinical trials in medical oncology conducted by the Developmental Therapeutics Clinic at the NIH Clinical Center. Although some of these specimens require only routine handling and processing, such as plasma or serum for analysis of drug levels, other specimens require highly specialized and immediate processing to yield valid assay results later on, for example, peripheral blood mononuclear cells and tumor biopsies. Technical support includes staffing and materials required to interact closely with the clinical staff coordinating the collection of clinical research samples from patients, and then to process those specimens into forms which stabilize the endpoints to be measured via cryopreservation or specialized reactions. In addition, the PK/PD Support Group packages processed specimens for distribution to analysis laboratories at the NCI, SAIC-F or collaborating institutions designated in the clinical protocol, or to repositories for long-term storage. The PK/PD Support Group maintains a database of samples received, processed and distributed to analysis sites, and follows a quality assurance program to ensure the highest possible accuracy and integrity in the handling of these clinical research specimens from cancer patients participating in early clinical trials within the Developmental Therapeutics Section.