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帮助结束长期成瘾（HEAL）计划的一部分，旨在加速科学解决方案，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。