DMPK CONSULTING SUPPORT SERVICES

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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.