SUBJECT MATTER EXPERT CONSULTANT FOR DRUG METABOLISM PHARMACOKINETICS [DMPK].

药物代谢药代动力学 [DMPK] 主题专家顾问。

• 批准号: 10814117
• 负责人: RONALD WHITE
• 金额: $ 2.31万
• 依托单位: WHITE GLOBAL PHARMA CONSU
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10814117
• 关键词: Address; Chemistry; Clinical Research; Contractor; Data; Data Analyses; Development; Drug Kinetics; Electronic Mail; Experimental Designs; Formulation; Investigational Drugs; Lead; Protocols documentation; Recommendation; Reporting; Services; Telephone; United States National Institutes of Health; assay development; design; drug development; drug discovery; drug metabolism; lead optimization; programs

Drug Metabolism Pharmacokinetics The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows: • Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges. • Develop plans to assist NIH BPN staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Assist NIH BPN staff to design investigative pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports are needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. • Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects.

药物代谢和药代动力学 承包商应向NIH蓝图神经治疗网络提供咨询支持服务， 如下所示： ·评估药代动力学研究方案和数据，以确定潜在的药物发现和开发 挑战提出应对这些挑战的战略建议。 ·制定计划，协助NIH BPN工作人员战略性地管理药代动力学项目，以促进分析 开发、探索性化学、电极导线优化、制剂活动、研究性新药（IND） 和临床研究。 ·协助NIH BPN工作人员设计调查性药代动力学研究，包括研究策略和实验 设计提供关于建议的研究里程碑的建议，并准备里程碑报告。 ·通过电话和电子邮件促进领导开发团队关于指定药物代谢的讨论 和药代动力学的努力。 ·分析和解释药代动力学药物发现，开发和转化项目的数据。