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: 10721124
• 负责人: PAUL PEARSON
• 金额: $ 1.32万
• 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/10721124
• 关键词: Address; Chemistry; Clinical Research; Consult; Contractor; Data; Development; Drug Kinetics; Electronic Mail; Experimental Designs; Formulation; Helping to End Addiction Long-term; Investigational Drugs; Lead; Pain; Pain management; Protocols documentation; 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. 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 帮助结束成瘾长期 (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。 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 提出应对这些挑战的策略。 • 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。