The long-term objective of the Pharmacology Shared Resource is to provide critical pharmacologic support, services, and expertise for Cancer Center investigators engaged in the development and evaluation of anticancer agents.
The specific aims of the Shared Resource are to provide the necessary services and expertise for: 1) the conduct of clinical pharmacokinetic studies performed through the vigorous NCI-funded Phase I and Phase II clinical trials programs in the Cancer Center, 2) for the conduct of pharmacogenetic studies performed in conjunction with appropriate early clinical trials and 3) for the conduct of preclinical pharmacology studies in support of Cancer Center investigator research. To accomplish these aims, the Shared Resource has state of the art capabilities and expertise for the sensitive and specific analysis of drugs and their metabolites in biological specimens, for structure elucidation and pharmacologic characterization of drug metabolites, for the conduct of clinical and preclinical pharmacokinetic studies using those assay methodologies, for the detailed analysis of pharmacokinetic data and for the conduct of pharmacogenetic studies using validated assays for determination of allelic variants of genes related to drug response. In addition. Shared Resource key personnel consult with Cancer Center investigators in the design of studies and the analysis and interpretation of pharmacologic data obtained in those studies. The services and expertise of this Shared Resource are available only to Cancer Center members and are prioritized based on funding source, nature of the studies (clinical or preclinical investigations), scientific needs of the investigator and priorities within the Cancer Center. The Director is responsible for overall selection, prioritization and oversight of activity within the Shared Resource. Conduct of specific experiments is assigned to laboratory personnel based on the nature of the proposed laboratory studies. The Shared Resource provides the mechanism to conduct all pharmacologic studies in one integrated environment with substantial scientific and economic efficiencies. During the current funding period, the Shared Resource has contributed to over 45 clinical pharmacology protocol-based studies in conjunction with Phase I and Phase II clinical trials encompassing pharmacokinetic and pharmacogenetic elements. The Shared Resource also provided preclinical pharmacologic support for 14 Cancer Center investigator-initiated laboratory projects either for grant-funded studies or in preparation for grant submissions.
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