Pharmacokinetics

药代动力学

• 批准号: 7714429
• 负责人: LAKSHMI PENDYALA
• 金额: $ 4.15万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-28 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714429
• 关键词: Anthracycline Antibiotics; Anthracyclines; Antimetabolites; Biological; Biological Assay; Budgets; Cancer Center Support Grant; Chemopreventive Agent; Clinical; Clinical Protocols; Computer software; Consultations; Data; Data Analyses; Development; Doctor of Philosophy; Drug Delivery Systems; Drug Kinetics; End Point; Fluorescence; Funding; Future; Gene Expression; Gold; Gold Compounds; 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; Sampling; Selenium; Selenium Compounds; Services; System; Taxane Compound; Therapeutic; Time; Topoisomerase; Tryptophan; United States Food and Drug Administration; Validation; Vitamin D; absorption; analog; base; cost effectiveness; detector; instrument; instrumentation; member; pharmacodynamic model; programs; quality assurance; small molecule; steroid hormone; taxane

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.

药代动力学/药效学于2005年1月被指定为开发资源 (PK/PD）资源是新的CCSG资源。其使命是支持临床和临床前药物 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剂 支持.它还为研究人员提供小分子定量。资源分为两部分 部分：由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部分由Josephia Muindi，MD，PhD指导。技术人员由 质谱师、1.5名全职研究助理和2名技术员。资源提供：1） 为方案、CTEP/LOI和赠款准备的PK/PD研究提供咨询和意见; 2）开发和 验证新小分子的分析测定; 3）从生物样品中提取药物/代谢物 通过LC/MS/MS、UPLC、HPLC、原子吸收进行基质和分析; 4）实时qRT-PCR基因 用于PD终点的表达测定;和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和一台原子吸收分光光度计组成 和实时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、维生素D/代谢物、靶向药物（舒尼替尼） 和其它分子如色氨酸、kyurenine和新生霉素。元素分析包括硒， 铂金和黄金该资源由一个指导委员会指导，并在研究所的支持下运作， 退款资源的未来计划是吸引更大的同行评审资助的CCSG计划用户 基础，为I/II期研究提供扩展支持，扩大技术人员，并增加荧光 检测器连接至UPLC系统。 该资源被所有六个计划使用，65%的用户是CCSG成员。CCSG中的$49，410 要求提供的支助占业务预算总额的9%。