SUBJECT MATTER EXPERT CONSULTANT FOR DRUG METABOLISM PHARMACOKINETICS [DMPK]

药物代谢药代动力学主题专家顾问 [DMPK]

• 批准号: 10788019
• 负责人: WILLIAM MARTIN
• 金额: $ 10.44万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788019
• 关键词: Address; Chemistry; Clinical Research; Contractor; Data; Data Analyses; Development; Drug Kinetics; Electronic Mail; Experimental Designs; Formulation; Helping to End Addiction Long-term; Investigational Drugs; Lead; Pain; Pain management; Protocols documentation; Recommendation; Reporting; Services; Speed; Telephone; United States National Institutes of Health; assay development; clinical pain; design; drug development; drug discovery; drug metabolism; lead optimization; programs

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management; pain 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.

这项研究是 NIH 帮助消除成瘾长期 (HEAL) 计划的一部分，旨在加快科学解决方案的速度，以了解疼痛的基础并加强临床疼痛管理；疼痛 承包商应向 NIH 蓝图神经治疗网络提供咨询支持服务 如下： • 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策略建议。 • 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，以促进检测 开发、探索化学、先导化合物优化、制剂活动、研究性新药 (IND) 启用和临床研究。 • 协助 NIH BPN 工作人员设计药代动力学研究，包括研究策略和实验 设计。提供有关推荐研究里程碑的建议，并需要准备里程碑报告。 • 通过电话和电子邮件促进先导开发团队就指定药物代谢进行讨论 和药代动力学方面的努力。 • 分析和解释药代动力学药物发现、开发和转化项目的数据。