Pharmacokinetics

2005年1月被指定为开发资源，药代动力学/药效学 (PK/PD)资源是一种新的CCSG资源。它的使命是支持临床和临床前药物 通过使用灵敏的方法为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了小分子定量。该资源被组织为两部分 部分：Lakshmi Pendyala博士和类固醇指导的临床/临床前药物开发 荷尔蒙和维生素D部分由Josephia Muindi，医学博士执导。技术人员由一名 质谱学家，1.5FTE研究助理和两名技术人员。该资源提供：1) 为方案、CTEP/LOI和赠款准备的PK/PD研究提供咨询和投入；2)开发和 新小分子分析方法的验证；3)从生物中提取药物/代谢物 LC/MS/MS、UPLC、高效液相、原子吸收等分析方法；4)实时定量qRT-PCR PD终点的表达分析；5)PK数据分析。资源中的大型工具 包括两台LC/MS/MS仪器、两台HPLC、一台UPLC、一台原子吸收光谱仪 和实时QRT-PCR仪。小分子定量包括几种抗代谢物质， 紫杉烷、拓扑异构酶靶向剂、蒽环类药物、维生素D/代谢物、靶向剂(舒尼替尼) 以及其他分子，如色氨酸、绞股蓝和新胡萝卜素。元素分析包括硒， 白金和黄金。该资源由指导委员会指导，并在研究所的支持和 按存储容量使用计费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，扩大对I/I期研究的支持，扩大技术人员队伍，增加荧光 探测器连接到UPLC系统。 所有六个计划都使用该资源，65%的用户是CCSG成员。CCSG中的49,410美元 请求提供支助，占业务预算总额的9%。

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.