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

药物代谢与药代动力学 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，并就建立与DMPK相关的里程碑向NIH工作人员提供建议。具体的咨询责任将取决于个别顾问的专业知识和个别项目的需要。与DMPK相关的咨询服务可能需要临时提供，也可能需要通过LDTS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，以促进分析开发、探索性化学、铅优化、配方活动、IND支持和临床研究。 ·担任PK专家，以确定潜在的药物发现和开发挑战，如线索识别和领导开发，并提出应对这些挑战的战略建议。 ·合作设计调查性PK研究、PK/PD战略、实验设计、数据分析和解释，用于发现和翻译项目，以支持NIH药物发现和开发项目。

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.