DMPK CONSULTING SUPPORT SERVICES

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。具体的咨询职责 将取决于个人顾问的专业知识和个人需求 项目。可能需要与DMPK相关的临时咨询服务或 LDTS。 药物代谢和药代动力学顾问的作用可能包括但不包括 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，以促进化验 开发，探索化学，铅优化，配方活动， IND使能和临床研究。 ·担任PK专家，以确定潜在的药物发现和 发展挑战，如潜在客户识别和潜在客户发展以及 提出应对这些挑战的策略。 ·合作设计调查性PK研究、PK/PD策略、实验 发现和翻译项目的设计、数据分析和解释 支持美国国立卫生研究院药物发现和开发项目。

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.