The Chesapeake-Ohio Pharmacokinetics Core for The ETCTN

切萨皮克-俄亥俄州药代动力学核心(CHOP-KC)将提供最先进和高效的 生物分析服务，设计临床药理学研究并将其整合到临床方案中 实验治疗学临床试验网络的开发、样本分析和数据解释 (ETCTN)。CHOP-KC由俄亥俄州约翰霍普金斯大学分析药理学核心所组成 州立大学药物分析共享资源，马里兰大学翻译中心 医学。CHOP-KC的成立是为了最大限度地利用专业知识、基础设施和能力，并确保 有足够的能力实现提供世界级生物分析和临床药理学支持的目标 包括每年分析多达7,500个药代动力学(PK)样本。我们 组建了一个由高度协作的临床和翻译药剂师组成的互动团队(Dr. 米歇尔·鲁德克(MPI)、莎琳·贝克(Sharyn Baker)、米奇·菲尔普斯和亚历克斯·斯帕雷博姆)、药物计量学家(Dr. 菲尔普斯和乔加·戈布鲁)，以及统计学家(加里·罗斯纳博士)，他们在抗癌药物方面有坚实的基础 发展。我们将利用我们丰富的药理学经验为ETCTN提供研究设计支持， 开发、生成、分析和解释高质量数据以提高评估效率 以及开发新的癌症治疗方法，并对癌症患者的临床护理产生积极影响。这个 CHOP-KC在提供临床药理学和药物开发支持方面经验丰富 早期临床试验，并在各种NCI合作组织中拥有广泛的合作记录 协定资助的实体，包括ETCTN(UM1CA186691和UM1CA186712)和相关项目 团队，艾滋病恶性联盟(UM1CA121947)和成人脑瘤联盟 (UM1CA137443)，除了支持研究人员发起的试验和非临床抗癌药物开发 在各自的机构和全国范围内。具体目标是：1)提供最先进、良好的实验室 实践(GLP)--对生物体液中抗癌药物和代谢物进行定量的质量评估；2) 通过提供临床药理学专业知识，为NCI ETCTN提供协作和积极的贡献 临床试验方案；以及3)提供药代动力学/药效学数据分析和解释 为安全高效的临床药物开发提供决策支持。CHOP-KC期待着申请 他们的集体专业知识惠及ETCTN临床试验和加速实验性治疗药物 发展。

The Chesapeake-Ohio Pharmacokinetics Core (ChOP-KC) will provide state-of-the-art and efficient bioanalytical service, design and integration of clinical pharmacology studies into clinical protocol development, sample analysis, and data interpretation to the Experimental Therapeutics Clinical Trials Network (ETCTN). The ChOP-KC consists of the Johns Hopkins University Analytical Pharmacology Core, The Ohio State University Pharmacoanalytical Shared Resource, and the University of Maryland Center for Translational Medicine. The ChOP-KC was formed to maximize expertise, infrastructure, and capabilities and to ensure adequate capacity to achieve the goal of providing world-class bioanalytical and clinical pharmacology support to the ETCTN, including analysis of up to approximately 7,500 pharmacokinetic (PK) specimens per year. We have assembled an interactive team of highly collaborative clinical and translational pharmacologists (Drs. Michelle Rudek (mPI), Sharyn Baker (mPI), Mitch Phelps and Alex Sparreboom), pharmacometricians (Drs. Phelps and Joga Gobburu), and statistician (Dr. Gary Rosner) that have a solid foundation in anticancer drug development. We will utilize our extensive pharmacology experience to support the ETCTN with study design, assay development, generation, analysis, and interpretation of high-quality data to enhance efficient evaluation and development of novel cancer therapies and to positively impact the clinical care of cancer patients. The ChOP-KC is experienced in providing clinical pharmacology and drug development support during the conduct of early phase clinical trials and has an extensive track-record of collaboration within various NCI Cooperative Agreements funded entities, including the ETCTN (UM1CA186691 and UM1CA186712) and associated Project Teams, AIDS Malignancy Consortium (UM1CA121947), and the Adult Brain Tumor Consortium (UM1CA137443), in addition to supporting investigator-initiated trials and non-clinical cancer drug development at their respective institutions and nationally. Specific Aims are: 1) To provide state-of-the-art, Good Laboratory Practice (GLP)-quality evaluations to quantitate anticancer drugs and metabolites in biological fluids; 2) To contribute collaboratively and actively in the NCI ETCTN by providing clinical pharmacology expertise to develop clinical trial protocols; and 3) To provide pharmacokinetic/pharmacodynamic data analysis and interpretation to support decision-making for safe and efficient clinical drug development. The ChOP-KC looks forward to applying their collective expertise to benefit ETCTN clinical trials and accelerate experimental therapeutic agent development.