DMPK CONSULTING SUPPORT SERVICES

DMPK 咨询支持服务

• 批准号: 10495521
• 负责人: PAUL PEARSON
• 金额: $ 1.32万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10495521
• 关键词: Address; Chemistry; Clinical Research; Consult; Consultations; Contractor; Data; Data Analyses; Development; Drug Kinetics; Experimental Designs; Formulation; Individual; Lead; Protocols documentation; Research Design; Role; Services; Strategic Planning; United States National Institutes of Health; assay development; design; drug development; drug discovery; drug metabolism; lead optimization; programs

Drug Metabolism and Pharmacokinetics (DMPK) consultants may be required to evaluate PK study protocols and data, assist with study design, and advise NIH staff on the establishment of milestones related to DMPK. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. DMPK-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Drug Metabolism and Pharmacokinetics consultant may include but is not limited to the following responsibilities and tasks: • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage pharmacokinetic (PK) programs to facilitate assay development, exploratory chemistry, lead optimization, formulation activities, IND enabling, and clinical studies. • Serve as the PK expert in order to identify potential drug discovery and development challenges such as lead identification and lead development and suggest strategies to address these challenges. • Collaborate on design of investigative PK studies, PK/PD strategy, experimental design, data analysis and interpretation for discovery and translational projects in support of NIH drug discovery and development projects.

药物代谢和药代动力学（DMPK）顾问可能需要 评估PK研究方案和数据，协助研究设计，并向NIH工作人员提供以下建议 建立与DMPK相关的里程碑。具体咨询责任 将取决于个人顾问的专业知识和个人的需求 项目DMPK相关的咨询服务可能需要临时或 LDTs。 药物代谢和药代动力学顾问的职责可能包括但不包括 仅限于以下职责和任务： ·与其他顾问，承包商和NIH工作人员合作，提供建议， 战略性规划和管理药代动力学（PK）计划，以促进分析 开发、探索性化学、电极导线优化、配方活动， IND启动和临床研究。 ·担任PK专家，以确定潜在的药物发现， 开发方面的挑战，如铅的识别和铅的开发， 提出应对这些挑战的战略。 ·合作设计研究性PK研究、PK/PD策略、实验性 设计，数据分析和解释的发现和翻译项目， 支持NIH药物发现和开发项目。