Pharmacokinetics

药代动力学

基本信息

批准号：
8300292
负责人：
MAX S. WICHA
金额：
$ 15.44万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-06-01 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8300292
关键词：
Advisory Committees Animal Model Antineoplastic Agents Applications Grants Biological Biological Assay Cancer Center Support Grant Clinical Clinical Investigator Clinical Research Clinical Trials Decision Making Development Developmental Therapeutics Program Dose Drug Kinetics Drug Monitoring Experimental Drug Development Goals Grant High Pressure Liquid Chromatography Human Joints Lead Legal patent Licensing Malignant Neoplasms Manuscripts Menin Phase Phase I Clinical Trials Phase II Clinical Trials Plasma Process Productivity Publications Regimen Research Personnel Resources Sampling Strategic Planning System Therapeutic Therapeutic Clinical Trial Tissues Translational Research University of Michigan Comprehensive Cancer Center abstracting cancer therapy cost effectiveness discount drug development drug discovery drug metabolism inhibitor/antagonist interest meeting abstracts member metabolic abnormality assessment pharmacokinetic model pre-clinical programs square foot

项目摘要

The Pharmacokinetics (PK) Core is a new core in the University of Michigan Comprehensive Cancer Center (UMCCC). PK core has four objectives to support UMCCC strategic goals for next five years: Objective 1: To support preclinical pharmacokinetics (PK) for lead compound selection and dose regimen optimization, which enhances anticancer drug discovery & development for Experimental Therapeutics Program of UMCCC. Objective 2: To support clinical pharmacokinetics (PK) and optimize dose regimen of anticancer drugs In clinical studies, which supports and increase investigator-initiated clinical trials (phase I and phase II) for Translational and Clinical Research Programs of UMCCC. Objective 3: To increase grants, publications, and patent applications with UMCCC members, Objective 4; To enhance Interactions among UMCCC members for preclinical experimental and clinical developmental therapeutics. PK Core has 3000 sq ft lab space, 3.5 FTE, four LC-MS end three HPLC systems. The PK core is operated under Core Director and Advisory Committee. In the last two years during its establishment, the PK core has supported preclinical and clinical pharmacokinetics in animal models and clinical trials of 341 compounds (97% from UMCCC) from 31 investigators (76% are UMCCC members). For instance, the PK core has supported IAP Inhibitor (AT-406) development to advance lo phase I clinical studies at UMCCC. The PK core also significantly contributed Mdm2 inhibitor development with joint patents together with UMCCC members, which was licensed by Sanofl-Aventis for $360M. The pharmacokinetic studies In PK core has resulted in 20 joint grant applications, 20 manuscripts, 7 meeting abstracts, and three patents with UMCCC members in the last two years. The PK core provides significant cost effectiveness with 50% discount to UMCCC members and enhances scientific Interactions with UMCCC members. The PK core expects to spend 60% effort (compounds and required effort) for preclinical pharmacokinetics in animal models and 40% effort (compounds and required efforts) for clinical pharmacokinetics in clinical trials.

药代动力学 (PK) 核心是密歇根大学综合癌症中心 (UMCCC) 的新核心。 PK 核心有四个目标来支持 UMCCC 未来五年的战略目标：目标 1：支持临床前药代动力学 (PK) 以进行先导化合物选择和剂量方案优化，从而增强 UMCCC 实验治疗计划的抗癌药物发现和开发。目标2：支持临床研究中抗癌药物的临床药代动力学（PK）并优化剂量方案，支持和增加研究者发起的UMCCC转化和临床研究项目的临床试验（I期和II期）。目标 3：增加 UMCCC 成员的拨款、出版物和专利申请，目标 4；加强 UMCCC 成员之间在临床前实验和临床开发治疗方面的互动。 PK Core 拥有 3000 平方英尺的实验室空间、3.5 FTE、四个 LC-MS 和三个 HPLC 系统。 PK核心由核心总监和顾问委员会负责运营。在其成立的过去两年中，PK核心支持了来自31名研究人员（76%是UMCCC成员）的341种化合物（97%来自UMCCC）的动物模型和临床试验的临床前和临床药代动力学。例如，PK 核心支持 IAP 抑制剂 (AT-406) 的开发，以推进 UMCCC 的 I 期临床研究。 PK 核心还与 UMCCC 成员共同获得联合专利，为 Mdm2 抑制剂的开发做出了重大贡献，并获得赛诺福安万特公司以 3.6 亿美元的价格许可。过去两年，PK core 的药代动力学研究已与 UMCCC 成员提交了 20 项联合资助申请、20 份手稿、7 份会议摘要和 3 项专利。 PK 核心为 UMCCC 会员提供 50% 的折扣，提供显着的成本效益，并增强与 UMCCC 会员的科学互动。 PK核心预计将60%的精力（化合物和所需的精力）用于动物模型中的临床前药代动力学，40%的精力（化合物和所需的精力）用于临床试验中的临床药代动力学。