? PHARMACOKINETICS AND INVESTIGATIONAL CHEMOTHERAPY SHARED RESOURCE The primary purpose of the Pharmacokinetics and Investigational Chemotherapy (PKIC) shared resource, considered a clinical research-oriented facility, is to provide a broad spectrum of pharmacological and pharmaceutical services essential to the conduct of preclinical and clinical research in oncology, drug discovery, drug evaluation, and related areas to members of the Duke Cancer Institute (DCI). DCI members receive priority access at all stages of support. The PKIC is composed of two services: the Pharmacokinetics/ Pharmacodynamics (PK/PD) service and the Investigational Chemotherapy Service (ICS). The Pharmacokinetics/Pharmacodynamics (PK/PD) services are provided by the PK/PD Core in support of Phase I/II clinical studies (study design, dosing regimen, plasma/tissue biopsy, PK analysis/modeling, results reporting and publication), as well as early translational/preclinical cancer drug development work (new drug candidate chemical and metabolic properties, drug formulation, bioanalytical assay development, plasma/tissue analysis, PK/PD modeling, and dosing regimen optimization for efficacy studies). In addition, the expertise and instrumentation for handling complex bio-fluids/tissue matrices is available for analysis of small molecules in a broad sense, thus complementing other bioanalytical resources in supporting mechanistic and biomarker cancer studies. The Investigational Chemotherapy Service (ICS) is available to all DCI investigators for preparing investigational drug products, maintaining drug accountability records and investigational drug inventories according to FDA and CTEP guidelines. ICS supports all phases of clinical research and utilizes USP797 and USP800 cleanrooms for sterile study drug preparation. ICS prepares hazardous, non-hazardous and viral vector study drugs. In addition, this service provides design consultation, professional staff education, and implementation services for clinical research studies. In 2018, the PKIC (PKPD/ICS) provided services to 86 (22/66) investigators, 81% (77%/83%) of whom were DCI members, accounting for 84% of total usage, from all 8 DCI Research Programs. Use of this shared resource by DCI Members contributed to 70 publications over the project period, 11 of which were in high impact journals (Impact Factor > 9), demonstrating the value of services offered by the resource.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA014236-46
Application #
9853598
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2020-01-01
Budget End
2020-12-31
Support Year
46
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Duke University
Department
Type
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Abdi, Khadar; Lai, Chun-Hsiang; Paez-Gonzalez, Patricia et al. (2018) Uncovering inherent cellular plasticity of multiciliated ependyma leading to ventricular wall transformation and hydrocephalus. Nat Commun 9:1655
Hudson, Kathryn E; Rizzieri, David; Thomas, Samantha M et al. (2018) Dose-intense chemoimmunotherapy plus radioimmunotherapy in high-risk diffuse large B-cell lymphoma and mantle cell lymphoma: a phase II study. Br J Haematol :
Fayanju, Oluwadamilola M; Park, Ko Un; Lucci, Anthony (2018) Molecular Genomic Testing for Breast Cancer: Utility for Surgeons. Ann Surg Oncol 25:512-519
Porter, Laura S; Fish, Laura; Steinhauser, Karen (2018) Themes Addressed by Couples With Advanced Cancer During a Communication Skills Training Intervention. J Pain Symptom Manage 56:252-258
Káradóttir, Ragnhildur T; Kuo, Chay T (2018) Neuronal Activity-Dependent Control of Postnatal Neurogenesis and Gliogenesis. Annu Rev Neurosci 41:139-161
Han, Peng; Liu, Hongliang; Shi, Qiong et al. (2018) Associations between expression levels of nucleotide excision repair proteins in lymphoblastoid cells and risk of squamous cell carcinoma of the head and neck. Mol Carcinog 57:784-793
Xu, Yinghui; Wang, Yanru; Liu, Hongliang et al. (2018) Genetic variants in the metzincin metallopeptidase family genes predict melanoma survival. Mol Carcinog 57:22-31
Abdi, Khadar; Kuo, Chay T (2018) Laminating the mammalian cortex during development: cell polarity protein function and Hippo signaling. Genes Dev 32:740-741
Lu, Min; Sanderson, Sydney M; Zessin, Amelia et al. (2018) Exercise inhibits tumor growth and central carbon metabolism in patient-derived xenograft models of colorectal cancer. Cancer Metab 6:14
Qian, Danwen; Liu, Hongliang; Wang, Xiaomeng et al. (2018) Potentially functional genetic variants in the complement-related immunity gene-set are associated with non-small cell lung cancer survival. Int J Cancer :

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