Preclinical Pharmacokinetic and Pharmacological Studies of Antitumor and other Th

抗肿瘤等药物的临床前药代动力学和药理学研究

• 批准号: 8851447
• 负责人: KELLY DANIELS
• 金额: $ 2.85万
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8851447
• 关键词: Area Under Curve; Biochemical; Biological; Biological Assay; Biological Availability; Biological Models; Body Fluids; Clinical Trials; Computing Methodologies; Contracts; Data; Development; Drug Formulations; Drug Kinetics; Drug or chemical Tissue Distribution; Elements; Half-Life; In Vitro; Investigation; Laboratories; Liquid substance; Membrane; Molecular; Peer Review; Permeability; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Pharmacology; Plasma; Plasma Proteins; Protein Binding; Research Personnel; Resources; Route; Sampling; Solubility; Solvents; Structure; System; Testing; Therapeutic Agents; Tissues; Toxicology; Tumor Tissue; Urine; Validation; Work; analytical method; base; cancer therapy; design; metabolic abnormality assessment; pharmacokinetic model; pre-clinical; preclinical efficacy; urinary

This contract provides a resource for conducting preclinical pharmacology, pharmacokinetic, and metabolism studies with candidate therapeutic agents selected for development by the Division of Cancer Treatment, NCI. Candidate therapies selected for study under this contract arise from peer-reviewed applications submitted to NCI by academic investigators, pharmaceutical companies, or others. Work carried out under the contract includes: (1) development of analytical methods to quantify the levels of test agents in plasma, urine, and other biological matrices; (2) plasma stability and protein binding studies; (3) pharmacokinetic characterization; (4) quantification and identification of metabolites; and (5) assessment of pharmacodynamic effects. The characterizations obtained from these pharmacokinetic investigations were used in the prioritization and selection of agents for further development; in the design of preclinical efficacy and toxicology studies or in regulatory submissions in support of clinical trials of selected agents.

该合同为使用 NCI 癌症治疗部门选择开发的候选治疗药物进行临床前药理学、药代动力学和代谢研究提供了资源。根据本合同选择用于研究的候选疗法来自学术研究人员、制药公司或其他机构提交给 NCI 的同行评审申请。根据合同开展的工作包括： (1) 开发定量血浆、尿液和其他生物基质中测试药物水平的分析方法； (2)血浆稳定性和蛋白结合研究； (3)药代动力学表征； (4)代谢物的定量和鉴定； (5)药效学评价。从这些药代动力学研究中获得的特征用于确定进一步开发药物的优先顺序和选择；在设计临床前功效和毒理学研究或在监管提交中支持选定药物的临床试验。