Shared Resource 13: Pharmaco Analytical (PhASR)

共享资源 13：药物分析 (PhASR)

• 批准号: 10333302
• 负责人: Mitch A Phelps
• 金额: $ 13.38万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-12 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10333302
• 关键词: Abbreviations; Address; Antineoplastic Agents; Aspirate substance; Biological; Biological Assay; Biological Products; Biomedical Research; Biometry; Biopsy; Bone Marrow; Budgets; Cancer Biology; Cancer Center Support Grant; Cancer Control; Cancer Hospital; Chemoprevention; Clinical; Clinical Protocols; Clinical Treatment; Clinical Trials; Clinical Trials Network; Comparative Pathology; Complex; Comprehensive Cancer Center; Data; Data Analyses; Development; Dose; Drug Delivery Systems; Drug Kinetics; Engineering; Enzyme-Linked Immunosorbent Assay; Enzymes; Experimental Designs; Flow Cytometry; Funding; Future; Genomics; Grant; Growth; Histone Deacetylase; Immunologic Monitoring; Immunooncology; Immunotherapy; Institutes; Intervention; Intramural Research Program; Investigational Therapies; Malignant Neoplasms; Measurement; Methods; Microscopy; Mission; Molecular Carcinogenesis; Neoplasm Circulating Cells; Nutrient; Ohio; Oligonucleotides; Oncology; Organ; Pediatric Hospitals; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Phase; Phytochemical; Proteomics; Publications; Regimen; Research; Research Design; Research Institute; Research Personnel; Resistance; Resource Sharing; Sampling; Service delivery model; Services; Specimen; Statistical Models; Surveys; System; Technology; Time; Translational Research; United States Food and Drug Administration; Universities; Validation; animal imaging; assay development; biomedical informatics; cancer therapy; clinical decision-making; clinical development; design; digital imaging; drug development; instrumentation; investigator-initiated trial; leukemia; leukemia tissue bank; liquid chromatography mass spectrometry; member; models and simulation; new technology; novel; pathology imaging; pharmacokinetic model; pharmacokinetics and pharmacodynamics; pre-clinical; preclinical development; programs; recruit; small molecule; targeted delivery; therapy development; translational genomics; translational scientist; translational therapeutics; tumor

PROJECT SUMMARY – PHARMACOANALYTICAL SHARED RESOURCE (PhASR) PhASR provides CCC members with expertise in pharmacokinetic (PK) and pharmacodynamic (PD) studies, including bioanalytical services to accurately quantify drugs, metabolites, and endogenous biomolecules in biological samples to support pre-clinical and clinical development of experimental cancer therapies. This support also includes experimental design, data analysis, modeling and simulation for characterizing PK/PD relationships and simulating optimal dose regimens for the advancement of anti-cancer therapies in pre-clinical and clinical development stages. PhASR was previously rated as Outstanding in the Analytical Shared Resource Group. There were no weaknesses noted, but it was recommended that PhASR plan for anticipated increases for future demand. PhASR’s Specific Aims are to: 1) develop and validate new assays to quantify drugs and metabolites in biological specimens; 2) quantify drug and metabolite levels in biological matrices, and conduct PK/PD studies for incorporation into pre-clinical and clinical decision-making; and 3) provide expertise in PK/PD study design and data interpretation to support submission of early phase 1 and 2 clinical protocols, grants, and publications. During the current 5-year funding cycle, PhASR supported 67 investigators in all five OUSCCC research programs and Nationwide Children’s Hospital, and supported 52 publications (8 with >10 impact factor) and 11 NCI grants, including 1 K22, 1 K24, 2 P01s, 2 P50s, 4 R01s, and 1 UM1. PhASR future services will address OSUCCC strategic priorities in translational genomics, immuno-oncology and cancer engineering. Given the robust OSUCCC recruitment, demand for services and new technologies will increase. The PhASR will expand its staff, instrumentation and services before capacity is reached. Recent and new technologies on order will enhance our efforts for accurate and sensitive measurements in samples of small quantity, focus on development of assays to accurately quantify immunotherapies and other biologics and increase statistical modeling services for PK/PD relationships at the cellular, tumor, organ, or whole body levels. The annual budget of the PhASR is $612,272 yet the CCSG request is $94,171. As such, the PhASR leverages extensive institutional support and seeks only 15.4% support from CCSG funds.

项目总结-药物分析共享资源（PhASR） PhASR为CCC成员提供药代动力学（PK）和药效学（PD）研究方面的专业知识， 包括生物分析服务，以准确定量药物，代谢物和内源性生物分子， 生物样品，以支持实验性癌症疗法的临床前和临床开发。这 支持还包括用于表征PK/PD的实验设计、数据分析、建模和模拟 关系和模拟最佳剂量方案，以促进临床前抗癌治疗 临床发展阶段。PhASR之前在分析共享资源中被评为杰出 组没有发现不足之处，但建议PhASR为预期的增加制定计划 未来的需求。PhASR的具体目标是：1）开发和验证新的检测方法来量化药物， 2）定量生物基质中的药物和代谢物水平，并进行 用于纳入临床前和临床决策的PK/PD研究;以及3）提供PK/PD方面的专业知识 研究设计和数据解释，以支持提交早期1期和2期临床方案、赠款， 出版物。在当前的5年资助周期中，PhASR支持了所有五个OUSCCC的67名研究人员 研究项目和全国儿童医院，并支持了52篇出版物（8篇影响因子>10） 和11项NCI赠款，包括1项K22、1项K24、2项P01、2项P50、4项R 01和1项UM 1。PhASR未来的服务将 解决OSUCCC在转化基因组学，免疫肿瘤学和癌症工程方面的战略优先事项。 鉴于OSUCCC的招聘势头强劲，对服务和新技术的需求将增加。Phasr 将在达到能力之前扩大其人员、仪器和服务。最近和新技术 订单将加强我们在小批量样品中准确和灵敏测量的努力，重点是 开发检测方法，以准确定量免疫疗法和其他生物制剂，并增加统计学 为细胞、肿瘤、器官或全身水平的PK/PD关系提供建模服务。年度预算 PhASR的要求是612，272美元，而CCSG的要求是94，171美元。因此，PhASR利用了广泛的 机构支持，仅寻求CCSG资金的15.4%支持。