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 Core在接下来的五年中有四个目标来支持UMCCC战略目标：目标1：支持临床前药代动力学（PK）进行铅复合选择和剂量方案优化，这增强了UMCCC实验治疗计划的抗癌药物发现和开发。目标2：在临床研究中支持临床药代动力学（PK）并优化抗癌药物的剂量方案，该研究支持并增加了研究人员发起的临床试验（I阶段和II期），用于UMCCC的转化和临床研究计划。目标3：与UMCCC成员提高赠款，出版物和专利申请，目标4；为了增强临床前实验和临床发育疗法的UMCCC成员之间的相互作用。 PK Core具有3000平方英尺的实验室空间，3.5 FTE，四个LC-MS结束三个HPLC系统。 PK核心在核心主任和咨询委员会下运营。在建立的过去两年中，PK Core在动物模型中支持了临床前和临床药代动力学，以及31种研究者的341种化合物（来自UMCCC的97％）的临床试验（76％是UMCCC成员）。例如，PK核心支持IAP抑制剂（AT-406）开发，以推进UMCCC I期临床研究。 PK Core还与UMCCC成员一起通过联合专利贡献了MDM2抑制剂的开发，该专利由Sanofl-Aventis许可以3.6亿美元的价格获得。在过去的两年中，PK Core的药代动力学研究导致了20个联合赠款申请，20份手稿，7次摘要和与UMCCC成员的3项专利。 PK Core可为UMCCC成员提供50％的折扣，并增强了与UMCCC成员的科学互动。 PK Core预计在动物模型中为临床前药代动力学花费60％的努力（化合物和所需的精力），在临床试验中为临床药代动力学花费40％的努力（化合物和所需的努力）。