NINDS BPN DMPK Consulting - White Global Pharma Consultants LLC IGF::CL::IGF

NINDS BPN DMPK 咨询 - White Global Pharma Consultants LLC IGF::CL::IGF

• 批准号: 10613333
• 负责人: RON WHITE
• 金额: $ 0.9万
• 依托单位: WHITE GLOBAL PHARMA CONSU
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-08 至 2022-06-07
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10613333
• 关键词: Address; Chemistry; Clinical Research; Consult; Consultations; Contractor; Data; Data Analyses; Development; Drug Kinetics; Experimental Designs; Formulation; Individual; Lead; National Institute of Neurological Disorders and Stroke; 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 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 可能需要药物代谢和药代动力学（DMPK）顾问评估PK研究方案和数据，协助研究设计，并就DMPK相关里程碑的建立向NIH工作人员提供建议。 具体的咨询责任将取决于个别咨询人的专门知识和个别项目的需要。DMPK相关咨询服务可能需要临时提供或在LDTs上提供。 药物代谢和药代动力学顾问的职责可能包括但不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，为药代动力学（PK）项目提供建议、战略规划和管理，以促进检测开发、探索性化学、先导化合物优化、制剂活动、IND启用和临床研究。 · 担任PK专家，以确定潜在的药物发现和开发挑战，如先导化合物识别和先导化合物开发，并提出应对这些挑战的策略。 · 合作设计研究性PK研究、PK/PD策略、实验设计、数据分析和解释，以支持NIH药物发现和开发项目的发现和转化项目。