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.

可能需要药物代谢和药代动力学（DMPK）顾问 评估PK研究协议和数据，协助研究设计，并建议NIH员工 建立与DMPK有关的里程碑 将取决于个人顾问的专业知识和个人需求 可能需要与DMPK相关的咨询服务 LDTS。 药物代谢和药代动力学顾问的作用可能包括但不包括 限于以下责任和任务： •与其他顾问，承包商和NIH员工合作，建议， 策略性地计划和管理药代动力学（PK）计划以促进测定 开发，探索性化学，铅优化，配方活动， IND启用和临床研究。 •作为PK专家，以确定潜在的药物发现和 发展挑战，例如铅识别和铅开发以及 提出解决这些挑战的策略。 •在调查性PK研究，PK/PD策略，实验方面进行合作 设计，数据分析和解释，用于发现和翻译项目 支持NIH药物发现和开发项目。