Pharmacokinetics

药代动力学

基本信息

批准号：
8375986
负责人：
LAKSHMI PENDYALA
金额：
$ 10.42万
依托单位：
ROSWELL PARK CANCER INSTITUTE CORP
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至 2014-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8375986
关键词：
Anthracyclines Antimetabolites Biological Biological Assay Budgets Cancer Center Support Grant Cancer Therapy Evaluation Program Chemopreventive Agent Clinical Clinical Protocols Computer software Consultations Cytoprotective Agent Data Data Analyses Development Doctor of Philosophy Drug Delivery Systems Drug Kinetics Fluorescence Funding Future Gene Expression Gold Grant Guidelines High Pressure Liquid Chromatography Human Resources Institutes Malignant Neoplasms Methods Mission Modeling Molecular Novobiocin Peer Review Pharmaceutical Preparations Pharmacodynamics Phase Platinum Polyamines Postdoctoral Fellow Preclinical Drug Development Preparation Preventive Protocols documentation Research Personnel Resources Retinoids Roswell Park Cancer Institute Sampling Selenium Services System Taxane Compound Therapeutic Time Topoisomerase Tryptophan Validation Vitamin D absorption analog base cost effectiveness detector instrument instrumentation liquid chromatography mass spectrometry member pharmacodynamic model programs quality assurance small molecule steroid hormone taxane

项目摘要

Designated as a developing resource in January 2005, the Pharmacokinetics/ Pharmacodynamics (PK/PD) Resource is a new CCSG Resource. Its mission is to support clinical and preclinical drug development at RPCI by providing quality analytical data using sensitive methods for PK/PD studies of cancer therapeutic and preventive agents with quality assurance, cost effectiveness and necessary modeling support. It also provides small molecule quantification for investigators. The Resource is organized into two sections: the Clinical/Preclinical Drug Development directed by Lakshmi Pendyala, PhD, and the Steroid Hormone and Vitamin D Section directed by Josephia Muindi, MD, PhD. Technical personnel consist of a Mass Spectrometrist, 1.5 FTE research associates and two technicians. The Resource provides: 1) consultation and input for PK/PD studies for protocol, CTEP/LOI and grant preparations; 2) development and validation of analytical assays for new small molecules; 3) extraction of drugs/ metabolites from biological matrices and analysis by using LC/MS/MS, UPLC, HPLC, Atomic Absorption; 4) real-time qRT-PCR gene expression assays for PD end points; and 5) PK data analysis. Large instrumentation in the Resource consists of two LC/MS/MS instruments, two HPLCs, one UPLC, an Atomic Absorption Spectrophotometer and a real-time qRT-PCR instrument. Small-molecular quantification includes several antimetabolites, taxanes, topoisomerase targeted agents, anthracyclines, Vitamin-D/metabolites, targeted agents (sunitinib) and other molecules such as tryptophan, kyurenine and novobiocin. Elemental analysis includes selenium, platinum and gold. The Resource is guided by a Steering Committee and operates on Institute support and chargebacks. Future plans for the Resource are to attract a larger peer-review-funded CCSG program user base, provide expanded support to Phase I/I I studies, expand the technical staff and add a fluorescence detector to the UPLC system. The Resource is used by all six Programs and 65% of users are CCSG members. $49,410 in CCSG support is requested, representing 9% of the total operating budget.

2005年1月被指定为开发资源，药代动力学/药效学 (PK/PD) 资源是新的 CCSG 资源。其使命是支持临床和临床前药物 RPCI 的开发通过使用敏感方法为 PK/PD 研究提供高质量的分析数据具有质量保证、成本效益和必要模型的癌症治疗和预防药物支持。它还为研究人员提供小分子定量。该资源分为两部分部分：Lakshmi Pendyala 博士指导的临床/临床前药物开发和类固醇激素和维生素 D 科由 Josephia Muindi 医学博士、哲学博士指导。技术人员由质谱师、1.5 名 FTE 研究助理和两名技术人员。该资源提供：1) 方案、CTEP/LOI 和拨款准备的 PK/PD 研究的咨询和投入； 2）开发和新小分子分析测定的验证； 3）从生物体中提取药物/代谢物使用 LC/MS/MS、UPLC、HPLC、原子吸收进行基质和分析； 4) 实时qRT-PCR基因 PD终点的表达测定； 5) PK数据分析。资源中的大型仪器由两台 LC/MS/MS 仪器、两台 HPLC、一台 UPLC、一台原子吸收分光光度计组成以及实时qRT-PCR仪器。小分子定量包括几种抗代谢物，紫杉烷类、拓扑异构酶靶向药物、蒽环类药物、维生素 D/代谢物、靶向药物（舒尼替尼）以及其他分子，例如色氨酸、犬尿氨酸和新生霉素。元素分析包括硒、铂金和黄金。该资源由指导委员会指导，并在研究所的支持和支持下运作退款。该资源的未来计划是吸引更多由同行评审资助的 CCSG 计划用户基地，为 I/I I 期研究提供扩大支持，扩大技术人员并增加荧光检测器连接至 UPLC 系统。该资源由所有六个计划使用，65% 的用户是 CCSG 成员。 CCSG 价值 49,410 美元请求支持，占总运营预算的 9%。