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PITT-CAL ETCTN PK Resource Laboratory

PITT-CAL ETCTN PK 资源实验室

基本信息

批准号：
10398219
负责人：
Jan Hendrik Beumer
金额：
$ 51.5万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-15 至 2026-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10398219
关键词：
Adopted Antineoplastic Agents Area Under Curve Award Biological Biological Assay Biological Markers Cancer Center Cancer Patient Cancer Therapy Evaluation Program Capital Cell Therapy Cities Clinical Clinical Research Clinical Trials Clinical Trials Network Comprehensive Cancer Center Consultations Core Facility Correlative Study Data Data Analyses Data Reporting Development Dose Drug Interactions Drug Kinetics Early Therapeutic-Clinical Trials Network Ensure Evaluation Excretory function Food Funding Future Goals Half-Life Infrastructure International Investigation Investigational Therapies Laboratories Laboratory Personnel Lead Leadership Life Cycle Stages Measures Metabolic Metabolism National Cancer Institute Pharmaceutical Preparations Pharmacodynamics Pharmacology Phase Philosophy Plasma Population Procedures Process Protocols documentation Quality Control Quality of Care Reagent Reporting Research Research Design Research Infrastructure Research Personnel Resources Sampling Science Specimen Testing Time Tissues Toxic effect Training U-Series Cooperative Agreements Writing absorption base clinical development data integration design drug development experience good laboratory practice instrumentation knowledge integration laboratory experience member multidisciplinary pharmacokinetics and pharmacodynamics pre-clinical research clinical testing response sample collection small molecule statistics

项目摘要

SUMMARY The purpose of this U24 Cooperative Agreement is to support a consortium of two National Cancer Institute (NCI)-Designated Comprehensive Cancer Center-funded pharmacokinetic (PK) core labs that have joined together as a consolidated, integrated PK resource for the NCI Experimental Therapeutics-Clinical Trials Network (ETCTN). The UPMC Hillman Cancer Center (HCC) Cancer Pharmacokinetics and Pharmacodynamics Facility and City of Hope (COH) Analytical Pharmacology Core Facility are nationally recognized for their leadership in the pharmacological characterization of anticancer agents. The newly formed PITT-CAL ETCTN PK Resource Laboratory (PITT-CAL) proposes to systematically evaluate the ADME profiles of CTEP agents in various phases of clinical development through the accomplishment of the following objectives: (1) To apply pharmacology expertise to the ETCTN early drug development efforts by assisting in study design and other PK-related activities; (2) To analyze biological samples with quantitative assays; and (3) To perform non-compartmental, compartmental, and population PK analyses and report the results to study teams and CTEP in a timely manner. Our approach will be to use our technical and scientific expertise to lead all PK-related activities and integrate these PK investigations with the other clinical and correlative studies performed during the drug development process. We will develop, validate, and implement accurate, precise, and sensitive assays for study drugs and metabolites in plasma, tissues and other biological samples, and analyze clinical samples from the ETCTN LOAs. Lastly, we will derive PK parameters to characterize the ADME of agents in ETCTN trials, integrate these results with pharmacodynamic measures of drug response and report to CTEP and the clinical team to optimally inform ongoing and future development of CTEP agents and their combinations.

总结